BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD VIO 27IN 1 S/A CT-1

    MDR report key: 22772100 · Received August 11, 2025

    Report

    Report Number
    2210968-2025-09226
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039056
    PMA / PMN Number
    K183183
    Adverse Event
    Yes
    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). 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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 SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 10, 120 ACTION TAKEN WHEN EVENT OCCURRED? SEARCHED FOR AND FOUND NEEDLE, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, IF NO, EXPLAIN: HAD TO PAUSE PROCEDURE TO SEARCH, XRAY REQUIRED PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, YES, XRAYS. ABDO CLOSED AND REOPENED AFTER IMAGING. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, NO, N/A. PRODUCT NAME: VCL CT BRD VIO 27IN 1 S/A CT-1 PRODUCT CODE: J341H LOT NUMBER: 105JG1. ADDITIONAL INFORMATION REQUESTED: WAS\WERE THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? IF YES, PLEASE EXPLAIN. YES, INITIALLY UNABLE TO VISUAL OR LOCATE BROKEN NEEDLE TIP. ABDO TEMP CLOSED AND IMAGINE COMPLETED WHICH CONFIRMED WAS STILL IN ABDOMEN. INCISION REOPENED. TEAM ATTEMPTED TO USE A MAGNET TO DRAW THE BROKE SHARP TIP OUT. EVENTUALLY WERE ABLE TO BRING IT TO VISUAL FIELD AND REMOVE. WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN NEEDLE PIECE(S)? SEE ABOVE. WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? YES WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? NO WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. YES, PATIENT HAD TO BE CONVERTED TO A GENERAL ANESTHETIC FOR REMAINDER OF PROCEDURE. EXTENDED OR LENGTH BY 2HRS TO LOCATE AND RETRIEVE. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. BROKEN NEEDLE PROVIDED TO (B)(6). PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). (B)(6) ¿ CLINICAL MANAGER, BIRTHING UNIT. 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, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WHAT WAS THE SIZE OF THE NEEDLE USED? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? 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? HAS THE PRODUCT BEEN SHIPPED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    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. ADDITIONAL INFORMATION: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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 PROCEDURE, THE NEEDLE BROKE IN TWO UPON THE CLOSURE PROCESS AND PART OF NEEDLE WAS LOST IN ABDOMEN. THE SURGERY DELAYED/PAUSED TO SEARCH FOR THE NEEDLE. INITIALLY, THE SURGEON WAS UNABLE TO VISUAL OR LOCATE BROKEN NEEDLE TIP. THE ABDOMEN WAS TEMPORARILY CLOSED AND IMAGINING WAS COMPLETED WHICH CONFIRMED THAT THE NEEDLE WAS STILL IN THE ABDOMEN. THE INCISION WAS REOPENED. THE TEAM ATTEMPTED TO USE A MAGNET TO DRAW THE BROKEN SHARP TIP OUT. EVENTUALLY, THE SURGEON WAS ABLE TO BRING IT TO VISUAL FIELD AND THE NEEDLE PIECE WAS REMOVED. THE PATIENT HAD TO BE CONVERTED TO A GENERAL ANESTHETIC FOR THE REMAINDER OF PROCEDURE. THE OR LENGTH WAS EXTENDED BY 2 HOURS TO LOCATE AND RETRIEVE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914281 VCL CT BRD VIO 27IN 1 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 105JG1 10705031039056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention