NA 8736685Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04055207020289), received between Nov 9, 2022 and Dec 20, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.

   Z-1425-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING AN FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, LOT # 4500330894. ACCORDING TO THE RECEIVED INFORMATION, A PROCEDURE TO REMOVE THE URETERAL STENT WAS PLANNED USING THE SURGICAL INSTRUMENT. "AFTER INSERTION INTO THE WORKING CHANNEL, THE FORCEPS WERE OPENED TO GRIP THE SPLINT. WHEN GRIPPING/CLOSING, THE JAWS BLOCKED. FORCEPS DID NOT CLOSE. AFTER ACTUATING THE GRIPPING DEVICE SEVERAL TIMES, THE FORCEPS FINALLY CLOSED. WE REMOVED THE FORCEPS AND ABORTED THE PROCEDURE TO PREVENT IT FROM BLOCKING AGAIN. THE INSTRUMENT WAS CHECKED FOR INTEGRITY BEFORE STERILIZATION. ALSO IMMEDIATELY BEFORE USE ON THE PATIENT. IT THEN FAILED DURING THE PROCEDURE." THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 18364762 ↗
• MalfunctionJun 2, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500098494. ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT DOES NOT OPEN PROPERLY. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO USE AND DEVICE WAS NOT BEING USED ON A PATIENT WHEN THE REPORTED ISSUE WAS IDENTIFIED. THERE WAS NO RISK TO THE PATIENT OR PERSONNEL REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051544 ↗
• MalfunctionJun 2, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500098494. ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT DOES NOT OPEN PROPERLY. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO USE AND DEVICE WAS NOT BEING USED ON A PATIENT WHEN THE REPORTED ISSUE WAS IDENTIFIED. THERE WAS NO RISK TO THE PATIENT OR PERSONNEL REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051482 ↗
• MalfunctionMay 26, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE ((B)(4)/ NOTIFICATION #: (B)(4)) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. IN RESPONSE TO THE NOTICE, THE CUSTOMER STATED THEY HAVE 2 FORCEPS THAT WERE OUT OF USE. THE SUSPECT DEVICE IS FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500352416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010243 ↗
• MalfunctionMay 26, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE (FSCA700020652 / NOTIFICATION #: 9611102-03-22-2023-001-C ) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. IN RESPONSE TO THE NOTICE, THE CUSTOMER STATED THEY HAVE 2 FORCEPS THAT WERE OUT OF USE. THE SUSPECT DEVICE IS FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500352416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010181 ↗
• MalfunctionMay 26, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE ((B)(4)/ NOTIFICATION #: (B)(4) ) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. IN RESPONSE TO THE NOTICE, THE CUSTOMER STATED THEY HAVE 2 FORCEPS THAT WERE OUT OF USE. THE SUSPECT DEVICE IS FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500352416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010073 ↗
• MalfunctionMay 26, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE ((B)(4) / NOTIFICATION #: (B)(4) ) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. IN RESPONSE TO THE NOTICE, THE CUSTOMER STATED THEY HAVE 2 FORCEPS THAT WERE OUT OF USE. THE SUSPECT DEVICE IS FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500352416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009987 ↗
• MalfunctionMay 18, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500338558. THE PART NUMBER AND BATCH OF THE REPORTED DEVICE IS INVOLVED IN THE RICHARD WOLF NOTIFICATION FSCA700020652 / 9611102-03-22-2023-001-C. IN RESPONSE TO THE NOTIFICATION, THE CUSTOMER IDENTIFIED 'THIS PIECE DOES NOT OPEN AT ALL'. GRASPER NOT OPENING PROPERLY PRIOR TO THE PROCEDURE. ACCORDING TO THE RECEIVED INFORMATION, THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN THE REPORTED ISSUE WAS IDENTIFIED. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO USE AND NO RISK TO PATIENT OR PERSONNEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955902 ↗
• MalfunctionMay 18, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 6.6FR WL 550MM, PART ID: 8736.685, BATCH # 4500338558. THE PART NUMBER AND BATCH OF THE REPORTED DEVICE IS INVOLVED IN THE RICHARD WOLF NOTIFICATION FSCA700020652 / 9611102-03-22-2023-001-C. IN RESPONSE TO THE NOTIFICATION, THE CUSTOMER IDENTIFIED 'THIS PIECE DOES NOT OPEN AT ALL'. GRASPER NOT OPENING PROPERLY PRIOR TO THE PROCEDURE. ACCORDING TO THE RECEIVED INFORMATION, THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN THE REPORTED ISSUE WAS IDENTIFIED. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO USE AND NO RISK TO PATIENT OR PERSONNEL WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955669 ↗
• MalfunctionMar 1, 2023Difficult to Open or Close; Difficult to Open or Close

  A USER FACILITY REPRESENTATIVE REPORTED AN ISSUE REGARDING FLEXIBLE GRASPER FORCEPS 6.6FR WL 550MM, PART NO. 8736.685, BATCH 4500356576. THE REPRESENTATIVE REPORTS "JAWS WILL NOT OPEN". ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON FEBRUARY 8, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A MINUTE DELAY WHILE RETRIEVING A BACK-UP DEVICE TO COMPLETE THE SCHEDULED PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464020 ↗
• MalfunctionMar 1, 2023Difficult to Open or Close; Difficult to Open or Close

  A USER FACILITY REPRESENTATIVE REPORTED AN ISSUE REGARDING FLEXIBLE GRASPER FORCEPS 6.6FR WL 550MM, PART NO. 8736.685, BATCH 4500356576. THE REPRESENTATIVE REPORTS "JAWS WILL NOT OPEN". ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON (B)(6) 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A MINUTE DELAY WHILE RETRIEVING A BACK-UP DEVICE TO COMPLETE THE SCHEDULED PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461932 ↗
• MalfunctionMar 1, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED AN ISSUE REGARDING FLEXIBLE GRASPER FORCEPS 6.6FR WL 550MM, PART NO. 8736.685, BATCH 4500367417. THE USER REPORTS "FORCEPS NOT FUNCTIONING PROPERLY. WILL NOT OPEN AND CLOSE WHEN INSIDE OF SCOPE. IF YOU DEFLECT THE SCOPE IT WILL NOT WORK.". ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 31, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 5 MINUTES WHILE RESOLVING THE ISSUE AND RETRIEVED A BACK-UP DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR RISK TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461923 ↗
• MalfunctionMar 1, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED AN ISSUE REGARDING FLEXIBLE GRASPER FORCEPS 6.6FR WL 550MM, PART NO. 8736.685, BATCH 4500367417. THE USER REPORTS "FORCEPS NOT FUNCTIONING PROPERLY. WILL NOT OPEN AND CLOSE WHEN INSIDE OF SCOPE. IF YOU DEFLECT THE SCOPE IT WILL NOT WORK." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 31, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 5 MINUTES WHILE RESOLVING THE ISSUE AND RETRIEVED A BACK-UP DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR RISK TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461893 ↗
• MalfunctionNov 9, 2022Material Twisted/Bent; Material Twisted/Bent

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE REGARDING PRODUCT ID# 8736.685, SN (B)(4) . INITIAL INFORMATION WAS "THE JAW WILL NOT OPEN." ADDITIONAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (COMPLAINT DATA COLLECTION QUESTIONNAIRE REPAIR CUSTOMER SERVICE) "SOMETIMES THE JAW OPENS, SOMETIMES IT DOESN'T." WILL THE DEVICE BE RETURNED? YES. 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. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. ADDITIONAL INFORMATIONS PROVIDED BY USER FACILITY REPRESENTATIVE: (EMAIL, DATED OCTOBER 26, 2022) 1. HOW LONG WAS THE PROCEDURE DELAYED? THE PROCEDURE WAS DELAYED FOR ONE WEEK. 2. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? THE PATIENT WAS SCHEDULED FOR A STENT REMOVAL. 3. DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760493 ↗
• MalfunctionNov 9, 2022Material Twisted/Bent; Material Twisted/Bent

  RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE COMPLAINT NO.(B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF DUE DILIGENCE FOR PATIENT INFORMATION. SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760358 ↗