BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10487561 · Received September 3, 2020

    Report

    Report Number
    3010692967-2020-00031
    Event Type
    Injury
    Date Received
    September 3, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A LOT NUMBER HAS NOT BEEN PROVIDED AND THEREFORE WE ARE UNABLE TO PERFORM A LOT REVIEW TO DETERMINE IF THERE WERE ANY NON-CONFORMANCES REPORTS WITH THIS ISSUE. THE NEEDLE IS AN ETHICON COMPONENT. TO DATE, A THIRD PARTY HAS NOT BEEN RECEIVED FROM ETHICON FOR THE NEEDLE.

    Additional Manufacturer Narrative · 0

    TO DATE, NO SAMPLES OR THIRD PARTY EVALUATION OF THE ETHICON COMPONENT WAS RECEIVED TO CONFIRM CONDITION OF THE NEEDLE/SUTURE DEVICE.

    Additional Manufacturer Narrative · 1

    TO DATE A LOT NUMBER HAS NOT BEEN PROVIDED AND THEREFORE WE ARE UNABLE TO PERFORM A LOT REVIEW TO DETERMINE IF THERE WERE ANY NON-CONFORMANCES REPORTS WITH THIS ISSUE. THE ACTUAL DEVICE WAS NOT RETURNED FOR REVIEW. NO STERILE DEVICES WERE RETURNED FOR TESTING OR REVIEW. A RETAINED SAMPLE WAS NOT AVAILABLE FOR REVIEW. IF SAMPLES BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED/TESTED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A POTENTIAL ROOT CAUSE FOR A NEEDLE DETACHING WHEN SLIGHTLY TUGGED DURING A PROCEDURE/ROBOTIC ASSIST PROCEDURE COULD BE THAT THE SUTURE WAS NOT FULLY INSERTED WITHIN THE END OF THE NEEDLE DURING THE MANUFACTURING PROCESS. IT¿S ALSO POSSIBLE THE DEVICE IS BEING GRASPED TOO CLOSE TO THE SWAGE AREA WITH THE NEEDLE HOLDER/FORCEPS. THE ¿PRECAUTIONS¿ SECTION IN THE IFU FOR THE STRATAFIX¿ DEVICE STATES, ¿CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS.¿ WITHOUT RECEIVING STERILE DEVICES FROM THE SAME LOT TO TEST, THE ACTUAL DETACHED DEVICE FOR REVIEW, MAGNIFIED PHOTOS OF THE DETACHED DEVICE OR RECEIVING DETAILED INFORMATION REGARDING THE STORAGE AND HANDLING OF THE DEVICE, EXPOSURE TIME PRIOR TO USE, PREOPERATIVE PREPARATION OF THE DEVICE, TOOLS UTILIZED TO GRASP THE DEVICE, PROCEDURE PERFORMED OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH FORM, MW (B)(4), DURING A ROBOTIC-ASSISTED PROSTATE RESECTION; FROM STAFF: A NEEDLE WAS DROPPED IN THE PATIENT'S PELVIS. THE PROCEDURE WAS NOT CLOSE TO CLOSING, AND NO COUNTS WERE/HAD BEEN MADE. THE SURGEON MADE THE DECISION TO SEARCH ROBOTICALLY. WHEN EXTRACTING THE NEEDLE WAS UNSUCCESSFUL, THE SURGEON CHOSE TO SEARCH AND FINISH THE PROCEDURE OPEN. THE NEEDLE WAS LOCATED, SUCCESSFULLY EXTRACTED, AND THE SURGERY WAS COMPLETED IN A NON-ROBOTIC, OPEN FASHION. COUNTS WERE CORRECT AT THE END OF THE PROCEDURE. FROM OP REPORT: A V-LOC STITCH WAS PLACED AT THE POSTERIOR SURFACE OF THE BLADDER FROM OUTSIDE-IN AND THEN PLACED IN THE URETHRA FROM INSIDE-OUT. AT THIS POINT IN TIME, IT WAS REALIZED THAT THE NEEDLE BROKE FROM THE SUTURE. AN ATTEMPT TO IDENTIFY THE LOCATION OF THE SUTURE WITH LAPAROSCOPIC VISION ALONE FAILED, AND X-RAY CONFIRMED THE POSITION OF THE NEEDLE ADJACENT TO THE FOLEY CATHETER. ADDITIONAL ATTEMPTS TO IDENTIFY THE NEEDLE, WHICH APPEARED TO BE CLOSE TO THE URETHRA, WITH LAPAROSCOPY ALONE DID NOT ALLOW TO IDENTIFY THE NEEDLE. THEREFORE, THE DECISION WAS TO EXTEND THE LOWER TROCAR INCISION TO PROVIDE ACCESS USING A BALFOUR TRACTOR, IN ADDITION TO A CYSTOSCOPE AFTER REMOVAL OF THE FOLEY CATHETER. USING THE CYSTOSCOPE, THE INNER PORTION OF THE STITCH/NEEDLE WAS VISUALIZED, AND THE NEEDLE WAS SUBSEQUENTLY RETRIEVED FROM THE ABDOMINAL SIDE. NEEDLE REMOVAL WAS COMPLETE. THERE WAS NO EVIDENCE OF FRAGMENTATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953961 STRATAFIX SUTURE 2RB-1 2-0 U MND 16X16 13MM LDR GAM SURGICAL SPECIALTIES SXMD2B402 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R