NA 82807Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207008195), received between Jun 1, 2022 and Oct 17, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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 4 most recent of 4 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. GRASP. FORCEPS 7FR WL 365MM, PART ID: 828.07, SERIAL NUMBER # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, IN (B)(6) 2023, DIFFICULTIES OCCURRED WITH THE FORCEPS DURING SEVERAL OPERATIONS. WITH THE GRASPING FORCEPS, A DOUBLE-J STENT COULD NOT BE GRASPED AND REMOVED, AS THEY COULD NOT BE OPENED/CLOSED PROPERLY, THUS NO GRASPING WAS POSSIBLE.

  Patient problems: Insufficient Information

  MAUDE report 17950946 ↗
• MalfunctionFeb 13, 2023Difficult to Open or Close; Difficult to Open or Close

  THE PHYSICIAN REPORTED THAT DURING A CYSTOSCOPY, HE HAS INSERTED THE FLEX. GRASP. FORCEPS 7FR WL 365MM, PART NO. 82807, VIA WORKING CHANNEL, BUT THE GRASPER COULD NOT BE OPENED. THE PHYSICIAN RETRIEVED THE GRASPER AND THE WORKING CHANNEL FROM PATIENT. THE GRASPER STILL WOULD NOT OPEN OUTSIDE THE PATIENT. ACCORDING TO THE USER, THERE WAS NO INJURY TO THE PATIENT. HOWEVER, THE SCHEDULED PROCEDURE WAS NOT COMPLETED. A FOLLOW-UP PROCEDURE WAS PERFORMED SUCCESSFULLY ON THE FOLLOWING DAY WITH AN EXCHANGE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16366911 ↗
• MalfunctionJun 1, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) BY THE CUSTOMER, THAT THEY "WERE UNABLE TO OPEN AND CLOSE GRASPING FORCEPS OR BIOPSY FORCEPS DURING A CASE." ADDITIONAL DETAILS: 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569376 ↗
• MalfunctionJun 1, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) BY THE CUSTOMER, THAT THEY "WERE UNABLE TO OPEN AND CLOSE GRASPING FORCEPS OR BIOPSY FORCEPS DURING A CASE." ADDITIONAL DETAILS: 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569368 ↗