BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLF LAPAROSCOPIC GRASPING FORCEP

    MDR report key: 11740937 · Received April 28, 2021

    Report

    Report Number
    1418479-2021-00016
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 1, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION (PRODUCT HISTORY EVALUATION REPORT), AND CHANGED INFORMATION. MISSING INFORMATION: USER FACILITY/SURGEON WAS CONTACTED 3 TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. AS OF 03/1/2022, RWMIC HAS NOT RECEIVED A RESPONSE. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS REPORT IS TO SUBMIT THE PRODUCT HISTORY EVALUATION REPORT TO THE FDA. THE DEVICE WAS NOT RETURNED TO RICHARD WOLF. PRODUCT HISTORY EVALUATION AS REPORTED BY RW GMGH: RICHARD WOLF GMBH HAS NOT RECEIVED ANY COMPLAINTS ABOUT THE FORCEPS 8642.65 OUTSIDE THE US SINCE YEAR 2014. THE COMPLAINT RATE OF THIS FORCEPS IS VERY LOW. BECAUSE THE INSTRUMENT WILL NOT BE RETURNED FOR INVESTIGATION, A DETAILED EVALUATION IS NOT POSSIBLE IN THIS CASE. BASED ON OUR EXPERIENCES OF OLDER COMPLAINTS THE MOST PROBABLE ROOT CAUSE OF THE DESCRIBED DAMAGE IS DUE TO OVERLOAD OF THE INSTRUMENT. AS THE FORCEPS HAS ONLY A DIAMETER OF 1.7MM AT DISTAL JAW PART THE INSTRUMENT IS NOT SUITABLE FOR APPLY EXCESSIVE FORCE. IN ORDER TO AVOID OVERLOADING, THE USERS ARE ADVISED IN THE IFU GA-E193 THAT THE PRODUCT HAS ONLY LIMITED STRENGTH. EXCESSIVE FORCE MAY CAUSE THE INSTRUMENTS TO BREAK. AS A RESULT OF THE NECESSARY SMALL DIMENSIONS, THE DISTAL SECTIONS OF THE INSTRUMENTS HAVE ONLY LIMITED STABILITY. AS THE REVIEW OF THE RELEVANT DATA DOES NOT SHOW SIGNS OF SYSTEMATIC ERRORS OR MANUFACTURING ERRORS, NO FURTHER ACTION IS NECESSARY. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RICHARD WOLF THAT "DURING THE PROCEDURE, A FORCEPS INSTRUMENT WITH GRASPERS WAS INSERTED INTO THE UTERUS. THE DEVICE WAS INITIALLY INTACT AND WAS INTRODUCED WITHOUT RESISTANCE OR DIFFICULTY. WHEN ATTEMPTING TO USE THE INSTRUMENT IT STOPPED WORKING. UPON REMOVAL A SMALL PIECE OF METAL PRESUMED TO BE A SCREW WAS NOTICED FLOATING IN THE SOLUTION THAT HAD BEEN INSTILLED INTO THE UTERUS. ATTEMPTS WERE MADE TO SNARE IT UNTIL AT ONE POINT THE METAL PIECE COULD NO LONGER BE SEEN IN THE UTERUS. THE HYSTEROSCOPY WAS COMPLETED. FOLLOWING THE PROCEDURE A SEARCH WAS CONDUCTED FOR THE SCREW BUT IT COULD NOT BE FOUND." THERE WERE TWO OTHER EVENTS RECENTLY REPORTED OF METAL SCREWS COMING LOOSE FROM FORCEPS DURING HYSTEROSCOPIES. IN BOTH CASES THE SCREWS WERE RETRIEVED AND REMOVED. ORIGINAL PROCEDURE: HYSTEROSCOPY. ADDITIONAL INFORMATION: 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? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634625 WOLF LAPAROSCOPIC GRASPING FORCEP GRASPING FORCEP GEN RICHARD WOLF GMBH 8642.65 4500303443

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other