BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL VIO 27IN USP1

    MDR report key: 21307666 · Received February 4, 2025

    Report

    Report Number
    2210968-2025-01360
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031086685
    PMA / PMN Number
    K964072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. CORRECTED B5 NARRATIVE: IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE USING VIDEOENDOSCOPIC TECHNOLOGIES ON (B)(6) 2025 AND A SUTURE WAS USED. DURING UTERINE SUTURING, THE NEEDLE BROKE IN THE NEEDLE HOLDER IN THE THICKNESS OF THE UTERINE TISSUE. THE NEEDLE PIECE FELL INTO THE SEROUS-MUSCULAR LAYER OF THE UTERUS. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY. AFTER REMOVAL OF PART OF THE NEEDLE PIECE, A LAYER-BY-LAYER RESTORATION OF THE ANTERIOR ABDOMINAL WALL WAS PERFORMED. AFTER AWAKENING FROM ANESTHESIA, THE PATIENT'S CONDITION WAS POSITIVE AND CURRENTLY SATISFACTORY. ADDITIONAL INFORMATION WAS REQUESTED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WHERE WAS THE NEEDLE GRASPED DURING USE? WHAT WAS THE SIZE OF THE NEEDLE USED? WHAT WAS THE SIZE OF THE BROKEN NEEDLE FRAGMENT? WERE ALL THE NEEDLE PIECE(S) RETRIEVED DURING THE LAPAROTOMY? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WAS THE PATIENT TREATMENT ALTERED IN ANY WAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. WAS THERE ANY PATIENT IMPACT (IE. ADDITIONAL TREATMENT REQUIRED) AND/OR ADVERSE PATIENT OUTCOME DUE TO THE PROLONGED SURGERY? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H 6. INVESTIGATION FINDINGS: C22 ¿ PHOTO INVESTIGATION. 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\WERE THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? DURING THE ADDITIONAL INTERVENTION (LAPAROTOMY), PARTS OF THE NEEDLE WERE REMOVED. WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? NO X-RAYS WERE TAKEN TO DETECT PARTS OF THE NEEDLE, AS PART OF THE NEEDLE WAS VISUALLY IDENTIFIED AND LOCATED SUPERFICIALLY. WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? TO REMOVE THE BROKEN PART, A LAPAROTOMY WAS PERFORMED (AN INCISION IN THE ANTERIOR ABDOMINAL WALL), THE NEEDLE WAS REMOVED WITH A NEEDLE HOLDER. WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? - IN ORDER TO SEARCH FOR THE NEEDLE DURING THE INCISION OF THE ANTERIOR ABDOMINAL WALL, THE INTEGRITY OF ALL LAYERS OF THE ANTERIOR ABDOMINAL WALL (SKIN, SUBCUTANEOUS TISSUE, APONEUROSIS, MUSCLES, PERITONEUM) WAS VIOLATED. THERE WERE NO ADDITIONAL TISSUE DAMAGES AS A RESULT OF SEARCHING FOR PARTS OF THE NEEDLE. NAME OF PROCEDURE? THE NAME OF THE OPERATION DURING WHICH THE INCIDENT OCCURRED IS LAPAROSCOPY, MYOMECTOMY (ENUCLEATION OF MYOMATOUS NODES) USING VIDEOENDOSCOPIC TECHNOLOGIES. ADVERSE REACTIONS IN THE PATIENT, NOT SPECIFIED IN THE INSTRUCTIONS FOR USE OR THE OPERATING MANUAL FOR THE MEDICAL DEVICE, WHICH DEVELOPED AS A RESULT OF THIS INCIDENT, MANIFESTED THEMSELVES IN AN INCREASE IN THE VOLUME OF THE OPERATION DUE TO THE TRANSITION FROM LAPAROSCOPY TO LAPAROTOMY, WHICH ENTAILS AN INCREASE IN THE RISK OF COMPLICATIONS OF SURGICAL MANIPULATIONS IN THE ABDOMINAL CAVITY, A LONGER RECOVERY PERIOD AFTER SURGERY. AFTER STOPPING THE UNDESIRABLE EVENT (REMOVAL OF PART OF THE NEEDLE), A LAYER-BY-LAYER RESTORATION OF THE ANTERIOR ABDOMINAL WALL WAS PERFORMED. AFTER AWAKENING FROM ANESTHESIA, THE PATIENT'S CONDITION IS POSITIVE, CURRENTLY SATISFACTORY. SIMILAR INCIDENTS HAVE NOT OCCURRED BEFORE. PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS AN OPEN BOX. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE OR THE REPORTED CONDITION. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. 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 A LAPAROSCOPY, MYOMECTOMY (ENUCLEATION OF MYOMATOUS NODES) PROCEDURE USING VIDEOENDOSCOPIC TECHNOLOGIES ON (B)(6) 2025 AND A SUTURE WAS USED. DURING UTERINE SUTURING, A NEEDLE BROKE IN THE NEEDLE HOLDER IN THE THICKNESS OF THE UTERINE TISSUE AFTER THE INITIAL USE OF THE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060790 MONOCRYL VIO 27IN USP1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. SDMEMU 10705031086685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention