BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID GRASPER FORCEPS

    MDR report key: 15013830 · Received July 14, 2022

    Report

    Report Number
    9611102-2022-00031
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    April 28, 2022
    Report Date
    October 25, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER RICHARD WOLF GMBH. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH THE RESULTS OF THE DEVICE INVESTIGATION (PRODUCT HISTORY EVALUATION) REGARDING THIS MDR. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: B4, B5, G6, H2, H3 (NOT RETURNED TO MANUFACTURER), H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), AND H10. THE RESULTS OF THE REQUEST FOR DEVICE RETURN: ON JULY 6, 2022, RWMIC HAS REQUESTED THE USER FACILITY FOR THE RETURN OF THE DEVICE. A REPAIR RETURN AUTHORIZATION DOCUMENT NO. 200421455, (FORM 3043 08) HAS BEEN ISSUED. CURRENTLY, RWMIC HAS NO RECORD OF DEVICE BEING RETURNED. SINCE DEVICE WAS NOT RETURNED, THE MANUFACTURER, RWGMBH, HAS PERFORMED AND COMPLETED A PRODUCT HISTORY EVALUATION IN LIEU OF THE ACTUAL DEVICE INVESTIGATION. THE RESULTS OF THE PRODUCT HISTORY EVALUATION: (RWGMBH, INVESTIGATION REPORT PRODUCT HISTROY EVALUATION, FORM 5253 (00). DATED, 10/25/2022. THE REPORTED DEVICE RIGID GRASP FORCEPS 5FR WL 430MM 8642.65 FROM BATCH #4500170290 WAS PRODUCED ON 06/18/2015 AND IT CONTAINS 43 PIECES. ALL 43 PIECES WERE SOLD TO RWMIC TILL 07/29/2015. RWGMBH HAS NO RECORDS ABOUT WHEN THE AFFECTED END USER RECEIVED THE DEVICE IN QUESTION. THERE IS NO OTHER COMPLAINTS FROM THE SAME BATCH. SINCE THE REPORTED DEVICE WON'T BE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE MALFUNCTION CANNOT BE DETERMINED. BASED ON THE RECEIVED INFORMATION AS WELL AS ON OLDER COMPLAINTS, THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS MECHANICAL OVERLOAD. THE COMPLAINT DATABASE AT RWGMBH HAS BEEN REVIEWED BETWEEN 01/01/2019 AND 07/16/2022. RWGMBH HAS RECORDED 3 COMPLAINTS REGARDING THE DEVICE 8642.65: 700017515 FROM BELGIUM. 700018299 / 22-00185 (CURRENT COMPLAINT) FROM THE US. THE DEVICE OF COMPLAINT (B)(4) WAS RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE REPORTED ISSUE OF COMPLAINT (B)(4) WAS MECHANICAL OVERLOAD. THE DEVICES OF THE FOLLOWING COMPLAINTS WERE NOT RETURNED FOR INVESTIGATION: 70017391 / 21-00129. 700018299 / 22-00185 (CURRENT COMPLAINT). THE PRODUCT HISTORY EVALUATIONS ARE AVAILABLE FOR THESE COMPLAINTS. IN THE RELEVANT IFU GA-E193 / USA / 2011-08 V1.0 / ECO 2011-0319, THE USER IS ADVISED IN SECTION 5 CHECKS ABOUT THE CONTROL OF THE DEVICE FOR DAMAGE AND COMPLETENESS AS WELL AS IN SECTION 6 APPLICATION ABOUT THE LIMITED STRENGTH OF THE DEVICE. IN THE RELEVANT RISK ASSESSMENT P08FO015 RISK ASSESSMENT - B 1-2: REUSABLE NON-OPTICAL FORCEPS AND SCISSORS, REV. R05, THE POSSIBLE RISK DUE TO FAILURE OF THE CORRESPONDING EXTEND OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE AND PROBABILITY OF REOCCURRENCE WERE CONSIDERED AND ASSESSED AS AN ACCEPTABLE RISK. RWGMBH CONSIDERS THIS MDR CLOSED. AN ADDITIONAL REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE COMPLAINT (B)(4). IT WAS REPORTED TO RWMIC THROUGH A MW5110124 REPORT THAT "WOLF 5FR RIGID FORCEP BROKE DURING USE WHILE TRYING TO RETRIEVE A POLYP. OPERATIVE AREA HAD TO BE SEARCHED AND IRRIGATED PROFUSELY TO LOCATE THE TINY FORCEP PIECES." DURING A HYSTEROSCOPY ENDOMETRIAL ABLATION, FORCEPS USED FOR TISSUE RETRIEVAL WERE NOTED TO BE BROKEN WHILE IN ENDOMETRIAL CAVITY. X-RAY DONE & MISSING PIECE WAS FOUND AND REMOVED. PATIENT OUTCOME: THERE WAS NO PATIENT IMPACT OR ANY AFTER EFFECTS DURING THE PROCEDURE. RWMIC MDR AWARENESS DATE: 06/17/2022. ADDITIONAL INFORMATION PROVIDED BY THE INITIAL REPORTER: 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? UNKNOWN. (HOWEVER; THERE IS DOCUMENTATION TO SUGGEST THERE WAS A DELAY). DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. THE INITIAL REPORTER ALSO INDICATED THAT AN "XR WAS CALLED IN TO HELP LOCATE THE BROKEN PIECE."

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION. SEE H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349964 RIGID GRASPER FORCEPS RIGID GRASP. FORCEPS 5FR WL 430MM GEN RICHARD WOLF GMBH 8642.65

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other| R HTA DEVICE - WOLF SCOPE