Direct Drive Reposable Graspers C4119Recalls & reported problems
Applied Medical Resources Corporation · Disposable Grasper Cartridge · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915116859), received between Nov 18, 2016 and Aug 14, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment Of Device Component3
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2017Detachment Of Device Component; Detachment Of Device Component
PROCEDURE PERFORMED: UNKNOWN. INCIDENT DESCRIPTION: (B)(4) INCIDENT REPORTED BY EMAIL BY CLINICAL PROCUREMENT. DETAILS OF THE COMPLAINT LISTED AS "THE BLUE PAD FROM THE TIP OF THE GRASPER CAME OFF". PATIENT STATUS: UNKNOWN. TYPE OF INTERVENTION: UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6793276 ↗MalfunctionFeb 1, 2017Detachment Of Device Component; Detachment Of Device Component
PROCEDURE PERFORMED UNKNOWN - "THREADS ON GRIPPING PAD BECAME DETACHED (VIEWED ON SCOPE)." PATIENT STATUS - "OK."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6294219 ↗MalfunctionNov 18, 2016Detachment Of Device Component; Detachment Of Device Component
"THE GRASPER WAS BEING USED IN A ADRENALECTOMY. STAFF NOTICED BLUE PIECES FROM MESH IN THE PATIENT WHICH THEY RETRIEVED." PATIENT STATUS: PATIENT IS OK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6115089 ↗
Other Laparoscopic Accessories, Gynecologic devices
- Epix Laparoscopic Grasper C4130Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic35 reports
- Direct Drive Reposable Graspers C4120Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic28 reports
- Direct Drive Reposable Graspers C4121Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic15 reports
- Epix Laparoscopic Grasper C4140Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic5 reports
- N/AStryker Sustainability Solutions, Inc. · Laparoscopic accessories, gynecologic2 reports
- Direct Drive Laparoscopic Grasping System C5223Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic1 report
- T'Lift® AW16280Peters Surgical · Laparoscopic Accessories, Gynecologic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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