NA 828051Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207009574), received between Mar 8, 2023 and Jun 13, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 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-1422-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE (FSCA700020652/ NOTIFICATION #: (B)(4) ) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 5FR WL 550MM, PART ID: 828.051, BATCH # 4500353558. THE COMPLAINANT CALLED ABOUT THE FORCEPS NOTIFICATION AND CHECKED THE DEVICES THEY HAD. SHE FOUND THAT 828.051 DEVICE HAD TROUBLE OPENING. THE DEVICE JAW WILL NOT OPEN SLOWLY/SMOOTHLY WHEN AT AN ANGLE. SHE DESCRIBED IT AS "FEELING THE FORCEPS CATCH". THE COMPLAINANT STATED THAT THE DEVICE WAS NOT BEING USED FOR A PROCEDURE. IT WAS CHECKED ONLY BECAUSE OF THE FSCA700020652 NOTICE. RWGMBH HAS VERIFIED THAT PART ID: 828.051, BATCH # 4500353558 IS AFFECTED BY THE FSCA700020652 NOTICE. THEREFORE, AN MDR REPORT IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121147 ↗
• MalfunctionJun 13, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RICHARD WOLF GMBH HAS ISSUED AN ADVISORY NOTICE (FSCA700020652 / NOTIFICATION #: (B)(4) ) REGARDING FLEX. GRASP. FORCEPS NOT FUNCTIONING PROPERLY. THE USERS ARE HAVING DIFFICULTY IN OPENING AND CLOSING THE GRASPERS. THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A FLEX. GRASP. FORCEPS 5FR WL 550MM, PART ID: 828.051, BATCH # 4500353558. THE COMPLAINANT CALLED ABOUT THE FORCEPS NOTIFICATION AND CHECKED THE DEVICES THEY HAD. SHE FOUND THAT 828.051 DEVICE HAD TROUBLE OPENING. THE DEVICE JAW WILL NOT OPEN SLOWLY/SMOOTHLY WHEN AT AN ANGLE. SHE DESCRIBED IT AS "FEELING THE FORCEPS CATCH". THE COMPLAINANT STATED THAT THE DEVICE WAS NOT BEING USED FOR A PROCEDURE. IT WAS CHECKED ONLY BECAUSE OF THE FSCA700020652 NOTICE. RWGMBH HAS VERIFIED THAT PART ID: 828.051, BATCH # 4500353558 IS AFFECTED BY THE FSCA700020652 NOTICE. THEREFORE, AN MDR REPORT IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121116 ↗
• MalfunctionMay 25, 2023Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE REGARDING 2 DEVICES OF FLEX. GRASP. FORCEPS 5FR WL 550MM, PART NO. 828.051, BATCH # 4500359201. THE USER FACILITY STATED ON THE 1ST DEVICE, "WHEN OPENING AND CLOSING THE GRASPER IT FEELS LIKE THERE IS A PINCH IN THE SHAFT OF THE GRASPER AND IT IS VISIBLE WHEN LOOK AT THE TIPS OPEN AND CLOSE." RWMIC ASSIGNED COMPLAINT # (B)(4) ON 1ST DEVICE. THIS WAS REPORTED UNDER IMPORTER MDR 1418479-2023-00006 AND MANUFACTURER MDR 9611102-2023-00015. A 2ND DEVICE WAS RETURNED TOGETHER WITH THE 1ST DEVICE. RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) ASSIGNED COMPLAINT # (B)(4). THE USER FACILITY SHIPPED BACK THIS DEVICE SINCE, BOTH DEVICES HAVE SIMILAR PRODUCT ID: 858.051 AND BELONGS TO THE SAME BATCH # 4500359201. ONLY THE 1ST DEVICE WAS INVOLVED IN THE REPORTED INCIDENT. ON 26/APR/2023, A PRELIMINARY DEVICE EVALUATION WAS PERFORMED WITH THE 2ND DEVICE (B)(4) AT RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC). ACCORDING TO THE RESPONSIBLE SERVICE DEPARTMENT, THE REPORTED CONDITION WAS CONFIRMED THAT THE JAWS DO NOT CLOSE CONSISTENTLY. HOWEVER, PHYSICAL CAUSE OF THE ISSUE COULD NOT BE DETERMINED. RWMIC DECIDED TO REPORT AS THE 2ND DEVICE EXHIBITS A SIM

  Patient problems: Insufficient Information

  MAUDE report 17002261 ↗
• MalfunctionMay 25, 2023Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE REGARDING 2 DEVICES OF FLEX. GRASP. FORCEPS 5FR WL 550MM, PART NO. 828.051, BATCH # 4500359201. THE USER FACILITY STATED ON THE 1ST DEVICE, "WHEN OPENING AND CLOSING THE GRASPER IT FEELS LIKE THERE IS A PINCH IN THE SHAFT OF THE GRASPER AND IT IS VISIBLE WHEN LOOK AT THE TIPS OPEN AND CLOSE." RWMIC ASSIGNED COMPLAINT (B)(4) (A) ON 1ST DEVICE. THIS WAS REPORTED UNDER IMPORTER MDR 1418479-2023-00006 AND MANUFACTURER MDR 9611102-2023-00015. A 2ND DEVICE WAS RETURNED TOGETHER WITH THE 1ST DEVICE. RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) ASSIGNED COMPLAINT (B)(4) (B). THE USER FACILITY SHIPPED BACK THIS DEVICE SINCE, BOTH DEVICES HAVE SIMILAR PRODUCT ID: 858.051 AND BELONGS TO THE SAME BATCH # 4500359201. ONLY THE 1ST DEVICE WAS INVOLVED IN THE REPORTED INCIDENT. ON (B)(6) 2023, A PRELIMINARY DEVICE EVALUATION WAS PERFORMED WITH THE 2ND DEVICE (B)(4) AT RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC). ACCORDING TO THE RESPONSIBLE SERVICE DEPARTMENT, THE REPORTED CONDITION WAS CONFIRMED THAT THE JAWS DO NOT CLOSE CONSISTENTLY. HOWEVER, PHYSICAL CAUSE OF THE ISSUE COULD NOT BE DETERMINED. RWMIC DECIDED TO REPORT AS THE 2ND DEVICE EXHIBITS A

  Patient problems: Insufficient Information

  MAUDE report 17002201 ↗
• MalfunctionMar 8, 2023Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE REGARDING FLEX. GRASP. FORCEPS 5FR WL 550MM, PART NO. 828.051, BATCH# 4500359201. THE USER REPORTS "WHEN OPENING AND CLOSING THE GRASPER IT FEELS LIKE THERE IS A PINCH IN THE SHAFT OF THE GRASPER AND IT IS VISIBLE WHEN LOOK AT THE TIPS OPEN AND CLOSE. DURING A CYSTOSCOPY STENT REMOVAL PROCEDURE, THE DOCTOR WAS UNABLE TO GRAB THE STENT DUE TO THE FAULTY EQUIPMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON (B)(6) 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 15 MINUTES IN THE PROCEDURE WHICH PUT THE PATIENT AT RISK. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16506441 ↗
• MalfunctionMar 8, 2023Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE REGARDING FLEX. GRASP. FORCEPS 5FR WL 550MM, PART NO. 828.051, BATCH# 4500359201. THE USER REPORTS "WHEN OPENING AND CLOSING THE GRASPER IT FEELS LIKE THERE IS A PINCH IN THE SHAFT OF THE GRASPER AND IT IS VISIBLE WHEN LOOK AT THE TIPS OPEN AND CLOSE. DURING A CYSTOSCOPY STENT REMOVAL PROCEDURE, THE DOCTOR WAS UNABLE TO GRAB THE STENT DUE TO THE FAULTY EQUIPMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON 24/FEB/2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 15 MINUTES IN THE PROCEDURE WHICH PUT THE PATIENT AT RISK. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16506372 ↗