Devices

Device Recall Direct Drive Grasper

  • 모델명 / 제조번호(시리얼번호)
    C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX: 1109421, 1109787, 1110340, 1119363, 1120205, 1120207, 1121053, 1121057, 1121624, 1121756, 1122974, 1123411, 1123710, 1123872, 1124355, 1124556, 1124717, 1125445, 1125447, 1125710, 1125887, 1126120, 1127581, 1127583, 1128329, 1128334, 1128336, 1128434, 1129471, 1129473, 1130479, 1131482, 1131483, 1131484, 1131485, 1131486, 1132587, 1133099, 1134795, 1134796, 1134799, 1135529, 1135553, 1136810, 1136814, 1137509, 1137511, 1138374, 1138557, 1139245, 1139247, 1139968, 1141460, 1141461, 1141462, 1141857, 1141859, 1142395, 1142398, 1143129, 1143130, 1143133, 1143609, 1144837, 1144838, 1144840, 1144841.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.
  • 제품 설명
    Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event

제조사

Applied Medical Resources Corp
  • 제조사 주소
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • 제조사 모회사 (2017)
    Applied Medical Corporation
  • Source
    USFDA

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Device Recall Direct Drive Grasper
  • 모델명 / 제조번호(시리얼번호)
    C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX:  1109789, 1110338, 1120502, 1121622, 1122986, 1125449, 1126857, 1128330, 1128927, 1129474, 1130990, 1131764, 1132586, 1136813, 1137334, 1139969, 1141463, 1142396, 1143131.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.
  • 제품 설명
    Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE || GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.
  • Manufacturer
    Applied Medical Resources Corp
Device Recall Direct Drive Grasper
  • 모델명 / 제조번호(시리얼번호)
    1112177, 1112935, 1123914, 1126274, 1132432, 1128149, 1129688, 1132432, 1133852, 1129688, 1133852, 1135372, 1136464, 1137996, 1139978, 1141874, 1144295, 1146403, 1125156, 1125279, 1126853, 1126853, 1130549, 1111831, 1111947, 1112024, 1125131, 1135284, 1139948, 1111842, 1138635, 1143347, 1111842, 1138635, 1143347, 1125499, 1132309, 1133063, 1134258, 1137548, 1138923, 1143888, 1146663, 1111843, 1130029, 1130029, 1139271, 1139365, 1145313, 1112273, 1124108, 1127084, 1131634, 1136135, 1127363, 1125662, 1125662, 1126390, 1127004, 1128850, 1130615, 1131158, 1136058, 1136556, 1139202, 1139316, 1139316, 1139316, 1135424, 1141142, 1146443, 1147253.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.
  • 제품 설명
    Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 || OR C4140 || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.
  • Manufacturer
    Applied Medical Resources Corp