Direct Drive Laparoscopic Grasping System C5223Recalls & reported problems
Applied Medical Resources Corporation · Reusable Grasper Handle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915116972), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2019Mechanical Problem; Mechanical Problem
CONNECTED THE REPOSABLE GRASPER SHAFT TO THE GRASPER HANDLE AND THE JAWS WOULDN'T OPEN AND CLOSE CORRECTLY. DISPOSABLE JAWS WOULD NOT ENGAGE CORRECTLY. TOOK IT APART AND CONNECTED IT TO ANOTHER HANDLE AND WORKED JUST FINE. RETURNING JUST THE HANDLE. PATIENT STATUS: PATIENT NOT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8756222 ↗
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
- Direct Drive Reposable Graspers C4119Applied Medical Resources Corporation · Laparoscopic Accessories, Gynecologic3 reports
- N/AStryker Sustainability Solutions, Inc. · Laparoscopic accessories, gynecologic2 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page