BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAP UD2/3-0 75CM 1A.PS2

    MDR report key: 18093564 · Received November 8, 2023

    Report

    Report Number
    2210968-2023-08652
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 26, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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 H6 INVESTIGATION FINDINGS: C22 - PHOTO REVIEW. ADDITIONAL H3 INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW A USED AND BROKEN NEEDLE. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE. BASED ON THE PHOTO REVIEW, 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 INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. 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. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. AFTER INVESTIGATION, THE PATIENT (FEMALE, SPECIFIC AGE UNKNOWN) UNDERWENT PERINEAL LACERATION REPAIR IN HOSPITAL ON (B)(6) 2023 DUE TO "PERINEAL LACERATION AFTER VAGINAL DELIVERY" (SPECIFIC DEGREE UNKNOWN). THE SURGEON USED W9923 FOR PERINEAL SKIN SEWING (SPECIFIC SUTURING METHOD UNKNOWN) DURING THE SURGERY. THE NEEDLE BROKE OCCURRED DURING THE SEWING (THE NEEDLE BREAKAGE WAS NEAR THE SWAGE AND ATTACHMENT AREA, THE SPECIFIC BREAKAGE LENGTH WAS UNKNOWN). THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY. THE SURGEON IMMEDIATELY LOOKED FOR THE BROKEN NEEDLE FOR 1 HOUR AND DID NOT FIND IT. THE SURGERY WAS COMPLETED ROUTINELY. ON THE NEXT DAY AFTER THE SURGERY, CT WAS PERFORMED TO CONFIRM THE LOCATION OF BROKEN NEEDLE AND A SECOND SURGERY WAS PERFORMED TO REMOVE THE NEEDLE. THE PATIENT WAS IN STABLE CONDITION CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. CORRECTED INFORMATION: H6 HEALTH EFFECT - CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    (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. 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. A PHOTO UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PHOTO EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 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? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING RESULTS. DOES ANY PIECE OF THE BROKEN NEEDLE REMAIN RETAINED IN THE PATIENT? IF THE PIECE(S) WERE RETAINED, WHERE ARE THEY LOCATED/IN WHAT STRUCTURE? 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?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING THE SKIN OF THE PERINEUM. THE NEEDLE FELL INTO PATIENT'S BODY. THE DOCTOR SEARCHED FOR AN HOUR DURING THE SURGERY, BUT THE NEEDLE WAS NOT FOUND. ON THE NEXT DAY AFTER SURGERY, THE POSITION OF THE BROKEN NEEDLE WAS CONFIRMED BY CT AND WAS REMOVED. THE PATIENT IS STABLE NOW. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923142 VICRYL RAP UD2/3-0 75CM 1A.PS2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention