N/A (REF 174317)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825012557), received between Mar 29, 2018 and May 20, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2019Break; Break

  IT WAS REPORTED A LAPAROSCOPIC GRASPER (MODEL 174317) BROKE INSIDE THE PATIENT. THE SCREW IN THE GRASPER PORTION OF THE TIP CAME OUT. THEY SEARCHED FOR THE SCREW BUT COULD NOT FIND IT DURING THE PROCEDURE. THE EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 10 MINUTES. THEY CONFIRMED VIA POST-OPERATION X-RAY THAT IT WAS LEFT INSIDE THE PATIENT. THE SURGEON DID SPEAK WITH THE FAMILY ABOUT THE INCIDENT AND OFFERED TO RETRIEVE THE SCREW. DOING SO WOULD HAVE REQUIRED RE-OPERATION AND AN OPEN PROCEDURE RATHER THAN A LAPAROSCOPIC ONE, WITH THE CHANCE OF BEING UNABLE TO RETRIEVE. THE FAMILY OPTED NOT TO PROCEED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION AND WILL FOLLOW A NORMAL POST-OPERATIVE COURSE. ON 9/13/2019, THE CUSTOMER REPORTED THE PATIENT HAD ONE POST-OPERATION FOLLOW UP APPOINTMENT WHICH WAS UNEVENTFUL. THERE HAS BEEN NO FURTHER CONTACT WITH THE PATIENT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8625864 ↗
• MalfunctionMar 29, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE DEVICE (LAPAROSCOPIC INSTRUMENT) DID NOT HOLD TISSUE PROPERLY. THE JAWS DID NOT CLOSE TIGHT ENOUGH TO GRAB TISSUE AND IT KEPT SLIPPING OFF. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7381680 ↗