BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARK

    MDR report key: 15084780 · Received July 22, 2022

    Report

    Report Number
    9611102-2022-00033
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 23, 2022
    Report Date
    August 17, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FJL
    UDI-DI
    04055207019658
    PMA / PMN Number
    K062720
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. DEVICE EVALUATION AND INSPECTION WAS PERFORMED BY RWMIC ON 05-JULY-2022. DEVICE INVESTIGATION RESULTS PROVIDED: RWMIC INVESTIGATION REPORT DEVICE EVALUATION, FORM 5020 (12). THE DEVICE WAS TESTED VISUALLY. THE REPORTED CONDITION WAS CONFIRMED AND THE DEVICE DID NOT MEET SPECIFICATIONS. THE EVALUATION FOUND THAT THE DAMAGE IS CONSISTENT WITH AN IMPACT AGAINST A HARD SURFACE. DAMAGE MAY HAVE CAUSED A THIN FRACTURE THAT HELP TOGETHER UNTIL THERE WAS STRESS ON THE DEVICE DURING USE OF BREAKING APART IMMEDIATELY. THE DEVICE WAS REPAIRED. ADDITIONAL INFORMATION REGARDING DEVICE LABELING INCLUDED. (B)(4), SECTION 8.1.2. "SHARK" RESECTOSCOPE, PG 27. WARNING! DANGER OF INJURY! INCORRECT HANDLING, E.G. FALL, SHOCK, BLOWS OR SIMILAR MECHANICAL LOADS CAN CAUSE HAIR CRACKS AND / OR SPALLING OF THE CERAMIC COATING IN THE DISTAL AREA OF THE RESECTOSCOPE SHEATH. INJURIES OF THE PATIENT, USER OR THIRD PARTIES ARE POSSIBLE. MIND SURFACE CHANGES AND ENSURE SAFE HANDLING. DO NOT USE DAMAGED RESECTOSCOPE SHEATHS, RETURN DAMAGED SHEATHS FOR REPAIR. CHECK THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTOSCOPE SHEATH FOR DAMAGE BEFORE EVERY USE. REPLACE DAMAGED OR BRITTLE O-RINGS / CAPS (12.13). O-RINGS (1.3) (1.5) - "SHARK" RESECTOSCOPE, ROTATABLE [A ] [ B ] O-RING (7.5) - "SHARK" RESECTOSCOPE WITH CENTRAL STOPCOCK [ C ] NON-ROTATABLE RW GMBH CONSIDERS THIS MDR OPEN. RW GMBH WILL SUBMIT A FOLLOW UP REPORT WHEN 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 NEW INFORMATION RECEIVED FROM THE USER FACILITY. RW GMBH CONSIDERS THIS MDR CLOSED. SHOULD RWGMBH RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) THAT "TIP BROKE OFF DURING A PROCEDURE. DELAY TIME WAS 15 MINUTES." ADDITIONAL INFORMATION REPORTED 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? 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. ADDITIONAL DETAILS ABOUT THE ADVERSE EVENT; (B)(6) 2022. (1) WHAT WAS THE SCHEDULED PROCEDURE BEING PERFORMED WHEN THE TIP BROKE? TRANSURETHRAL INCISION OF THE PROSTATE (TUIP). (2) DID THE TIP BREAK INSIDE OR OUTSIDE OF THE PATIENT? YES. (3) WHAT ACTIONS WERE BEING DONE DURING THE DELAY? REMOVE THE TIP OF THE SHEATH FROM THE PATIENT. (4) DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? NO. (5) WHAT WAS THE PATIENT'S OUTCOME? NO PROBLEM AT THE TIME OF DISCHARGE. RWMIC MDR AWARENESS DATE: (B)(6) 2022 ALSO, THE PURPOSE OF THIS SUBMISSION IS TO PROVIDE THE RESULTS OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 0

    RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) REFERENCE COMPLAINT: (B)(4). THE PURPOSE OF THIS REPORT IS TO UPDATE MDR WITH NEW PATIENT INFORMATION, RECEIVED FROM A REPRESENTATIVE OF THE USER FACILITY ON 8/16/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117304 SHARK INTERNAL SHEATH RESECTOSCOPE 24FR FJL RICHARD WOLF GMBH 8675324 04055207019658

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| O