BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24317689 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01538
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    May 16, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: PAK J MED SCI. 2025 JUN;41(6):1579-1585. HTTPS://DOI.ORG/10.12669/PJMS.41.6.10126 PMID: 40621549; PMCID: PMC12223757.

    Description of Event or Problem · 0

    TITLE: SURGICAL MANAGEMENT OF COMMON BILE DUCT STONES FOLLOWING REPEATED ENDOSCOPIC FAILURE: A RETROSPECTIVE COHORT STUDY COVERING THE PANDEMIC PERIOD. THIS STUDY EVALUATES THE CLINICAL OUTCOMES: BILE LEAKAGE, ONCOGENIC TRANSFORMATION, AND STONE RECURRENCE OF CHOLEDOCHODUODENOSTOMY (CDD) VERSUS T-TUBE DRAINAGE (TTD), AIMING TO SUBSTANTIATE THE SELECTION OF AN OPTIMAL CBD CLOSURE STRATEGY AFTER CHOLEDOCHOLITHOTOMY. BETWEEN JANUARY 1, 2016, AND AUGUST 1, 2021, A TOTAL OF 138 PATIENTS WHO UNDERWENT OPEN COMMON BILE DUCT EXPLORATION (OCBDE). PATIENTS WERE STRATIFIED INTO TWO COHORTS BASED ON THE SURGICAL TECHNIQUE EMPLOYED: CDD (GROUP-I) AND TTD (GROUP-II). CLINICAL AND SURGICAL OUTCOMES WERE METICULOUSLY COMPARED BETWEEN THE GROUPS. 109 (79%) WERE ASSIGNED TO GROUP-I (CDD) AND 29 (21%) TO GROUP-II (TTD). 77 (55.8%) WERE FEMALES AND 61 (44.2%) WERE MALES WITH THE MEAN AGE OF 61.6 PLUS OR MINUS 15.1 YEARS OLD. FOR CDD SURGERY, A MIDLINE INCISION USED TO EXPOSE THE ANTERIOR ASPECT OF THE CBD, FOLLOWED BY CHOLECYSTECTOMY IF NOT PREVIOUSLY PERFORMED. A LIMITED KOCHER MANOEUVRE IS PERFORMED TO REDUCE THE TENSION OF THE DUODENUM TO BE USED FOR DUODENAL ANASTOMOSIS. DUODENOTOMY IS PERFORMED LONGITUDINALLY TO THE 1ST CONTINENT AND BILIARY AND DUODENAL INCISIONS LIE PERPENDICULAR TO EACH OTHER FOR CREATING DIAMOND SHAPED ANASTOMOSIS. KEY STEPS INCLUDED THE PLACEMENT OF TWO 4/0 SILK OR VICRYL SUTURES FOR TRACTION AT THE LOWER END OF THE CBD, A 2 CM LONGITUDINAL CHOLEDOCHOTOMY, DEBRIS REMOVAL WITH RANDALL FORCEPS, AND SALINE IRRIGATION. THE BILE DUCTS WERE EXAMINED INTRAOPERATIVELY FOR RETAINED STONES OR OTHER LESIONS USING FLUOROSCOPY GUIDED CHOLANGIOGRAM AND/OR CHOLEDOCHOSCOPE BEFORE CREATING A DIAMOND-SHAPED SIDE-TO-SIDE ANASTOMOSIS WITH INTERRUPTED VICRYL 4/0 SUTURES. FOR THE TTD GROUP, A SIMILAR INITIAL APPROACH WAS FOLLOWED BY THE PLACEMENT OF A SUITABLY SIZED RUBBER T-TUBE AFTER STONE AND DEBRIS CLEARANCE. THE PROCEDURE AIMED TO FACILITATE FUTURE BILIARY ACCESS AND MANAGE POTENTIAL COMPLICATIONS. FOR BOTH SURGICAL PROCEDURES FROZEN PATHOLOGY WAS STUDIED IN CASE OF SUSPICION FOR MALIGNANCY. A JACKSON-PRATT DRAIN WAS POSITIONED LATERALLY TO THE ANASTOMOSIS, TARGETING MORRISON¿S POUCH. THE MEAN DURATION FOLLOW-UP WAS 18 (0-84) MONTHS POSTOPERATIVELY. REPORTED COMPLICATIONS: 4/0 VICRYL SUTURE (ETHICON): 4/0 SILK SUTURE (ETHICON): (N=13 (92.9%)) PATIENTS HAD WOUND SITE INFECTION TREATMENT: NOT REPORTED (N=7 (87.5%)) PATIENTS HAD BILE LEAKAGE TREATMENT: WERE MANAGED CONSERVATIVELY (ONE PATIENT¿S DRAIN, WHICH WAS INADVERTENTLY BREACHED THE CDD ANASTOMOSIS LINE ON GASTROSCOPIC CONTROL, WAS WITHDRAWN). (N=1 (100%)) PATIENT HAD PANCREATITIS TREATMENT: NOT REPORTED (N=1 (100%)) PATIENT HAD CHOLANGITIS TREATMENT: NOT REPORTED (N=3 (100%)) PATIENTS HAD HEMATOMA TREATMENT: NOT REPORTED. IN CONCLUSION, THE SIDE-TO-SIDE DIAMOND-SHAPED CHOLEDOCHODUODENOSTOMY DEMONSTRATED A LOWER INCIDENCE OF CHOLANGITIS AND RECURRENT STONES COMPARED TO TTD SURGERY, SUGGESTING ITS EFFICACY IN COMPLEX CBDS MANAGEMENT. HOWEVER, PATIENTS UNDERGOING BILIOENTERIC DRAINAGE SURGERIES REQUIRE CLOSE MONITORING IN THE POSTOPERATIVE PERIOD FOR POTENTIAL COMPLICATIONS, INCLUDING BILIARY TRACT MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380381 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention