BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 96IN 1 S/A XLH LP

    MDR report key: 22046188 · Received May 19, 2025

    Report

    Report Number
    2210968-2025-05536
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031061927
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO. HOW LONG WAS THE DELAY? PLEASE SPECIFY IN MINUTES. 30-45 MINUTES. DID ANY NEEDLE PIECE(S) FALL INTO THE PATIENT? UNKNOWN. IF YES, WAS\WERE THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? NO. WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? YES. WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? THE MULTIPLE EFFORTS (LOOKING TO THE STERILE FIELD DRAPE - ABDOMINAL X-RAY - MAGNET ROLLER ON THE FLOOR - STERILE MAGNET ON THE SURGICAL AREA) TO FOUND THE MISSING PIECE WAS UNFORTUNATELY UNSUCCESSFUL WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? NO WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, ACTION TAKEN WHEN EVENT OCCURRED? MULTIPLE EFFORTS (LOOKING TO THE STERILE FILED DRAPE-ABDOMINAL X-RAY-MAGNET ROLLER ON THE FLOOR-STERILE MAGNET ON THE SURGICAL AREA) TO FOUND THE MISSING PIECE WAS UNFORTUNATELY UNSUCCESSFUL., WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY. UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). ADDITIONAL INFORMATION: H 4. DEVICE MANUFACTURE DATE, H 6. TYPE OF INVESTIGATION A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE TLMLKB_Z881G BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE CLOSURE OF THE ABDOMINAL CAVITY WITH SUTURE THE SURGEON NOTICE THE TIP OF THE SUTURE NEEDLE WAS MISSING. THE STAFF REPORTED THAT DR. MENTIONED HEARING A SNAP AND SEEING SOMETHING FLYING. THE MULTIPLE EFFORTS (LOOKING TO THE STERILE FILED DRAPE-ABDOMINAL X-RAY-MAGNET ROLLER ON THE FLOOR-STERILE MAGNET ON THE SURGICAL AREA) TO FOUND THE MISSING PIECE WAS UNFORTUNATELY UNSUCCESSFUL. THE STAFF TOLD REP THIS MORNING THAT THE BROKEN NEEDLE HAS NOT BEEN KEPT AND ALSO THE LOT NUMBER WAS NOT KEPT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129625 PDSII VIO 96IN 1 S/A XLH LP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. TLMLKB 10705031061927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown