NA 837026Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814334021194), received between Mar 30, 2017 and Nov 9, 2021 — classified as 2 malfunctions.

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.

• MalfunctionNov 9, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE USER FACILITY TO RICHARD WOLF MIC THAT: "INSERTS JAWS WOULD NOT CLOSE AND COULD NOT GET INSTRUMENT THROUGH 5 MM TROCAR. HANDLE RATCHET ACTION WOULD NOT CLOSE JAWS. SURGEON WAS ABLE TO CLOSE JAWS THROUGH 2ND TROCAR WITH SECOND LAPAROSCOPIC INSTRUMENT" ADDITIONAL INFORMATION: WILL THE DEVICE BE RETURNED? NO. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. HOW LONG WAS THE DELAY? THE PROCEDURE CONTINUED WHILE THE INSTRUMENT WAS STUCK INSIDE THE PATIENT. ANY DELAY WAS MINIMAL. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. WILL THE CUSTOMERS RETURN THE ITEM 8370.26 THAT HAD MALFUNCTIONED DURING THE PROCEDURE? NO, THIS INSTRUMENT WAS RETURNED TO CSR AND THROWN AWAY. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? THE WOLF REP WAS CONTACTED TO DETERMINE IF THE INSTRUMENT COULD BE TAKEN APART OR IF CUTTING THE HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781725 ↗
• MalfunctionMar 30, 2017Break; Break

  NURSE FROM USER FACILITY NOTIFIED A (B)(4) SALES REPRESENTATIVE THAT DURING A CASE, ONE OF THE PRONGS ON THE DEVICE BROKE OFF IN PATIENT. PORTION WHICH BROKE OFF WAS EASILY RETRIEVED, A BACK UP DEVICE WAS READILY AVAILABLE AND PROCEDURE WAS COMPLETED WITH MINIMAL DELAY. NO INJURY TO PATIENT OR STAFF WAS REPORTED. DEVICE CONSISTS OF THREE PARTS: HANDLE, SHEATH, TENACULUM INSERT. HANDLE IS MANUFACTURED BY RWMIC AND THEN SENT TO ENDOPLUS WHERE THEY MANUFACTURE THE SHEATH AND TENACULUM INSERT. ENDOPLUS THEN COMBINES THE THREE PARTS AND RETURNS A COMPLETE DEVICE TO (B)(4) FOR DISTRIBUTION. MANUFACTURE DATE - AUG2011. CUSTOMER PURCHASE DATE - (B)(6) 2011. REQUEST FOR ADDITIONAL/MISSING INFORMATION HAS BEEN SENT TO USER FACILITY, NO RESPONSE AS OF 30MAR2017. DEVICE WAS HAS NOT YET BEEN RECEIVED AT (B)(4) AS OF 30MAR2017. DEVICE WILL BE SENT TO ENDOPLUS FOR INVESTIGATION IF AND WHEN IT IS RETURNED TO (B)(4). (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES THE DEVICE OR ANY ADDITIONAL INFORMATION, (B)(4) WILL PROVIDE MANUFACTURER OF THE TENACULUM (ENDOPLUS) WITH FOLLOW-UP INFORMATION/DEVICE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6445896 ↗