NA 82907Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207008249), received between Nov 22, 2019 and Oct 17, 2023 — classified as 3 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A FLEX. BIOPSY FORCEPS 7FR WL 375MM, PART ID: 829.07, SERIAL NUMBER # 4500377830. ACCORDING TO THE RECEIVED INFORMATION, IN (B)(6) 2023, DIFFICULTIES OCCURRED WITH THE FORCEPS DURING SEVERAL OPERATIONS. DURING A DJ URETERAL STENT PROCEDURE, THE PE (BIOPSY) FORCEPS MADE IT DIFFICULT TO REMOVE THE SAMPLES BECAUSE THE INSTRUMENT DID NOT OPENED AND CLOSED PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 17951742 ↗
• MalfunctionNov 22, 2019Difficult to Open or Close; Difficult to Open or Close

  ON OCTOBER 23, 2019 RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) RECEIVED THE FOLLOWING INFORMATION: PER THE CUSTOMER, THEY WERE UNABLE TO OPEN AND CLOSE GRASPING FORCEPS OR BIOPSY FORCEPS DURING A CASE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL. THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON OCTOBER 25, 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON NOVEMBER 12, 2019. THE DEVICE WAS FUNCTIONALLY EVALUATED. THE REPORTED CONDITION COULD NOT BE VERIFIED AS THERE WERE NO DEFECTS FOUND DURING EVALUATION. AS A RESULT, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365747 ↗
• MalfunctionNov 22, 2019Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2019 RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) RECEIVED THE FOLLOWING INFORMATION: PER THE CUSTOMER, THEY WERE UNABLE TO OPEN AND CLOSE GRASPING FORCEPS OR BIOPSY FORCEPS DURING A CASE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? GENERAL. THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON (B)(6) 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2019. THE DEVICE WAS FUNCTIONALLY EVALUATED. THE REPORTED CONDITION COULD NOT BE VERIFIED AS THERE WERE NO DEFECTS FOUND DURING EVALUATION. AS A RESULT, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365741 ↗