BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS SUTURE

    MDR report key: 25068210 · Received May 4, 2026

    Report

    Report Number
    2210968-2026-04814
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    August 26, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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: HPB (OXFORD). 2025 DEC;27(12):1503-1510. HTTPS://DOI.ORG/10.1016/J.HPB.2025.08.004 EPUB 2025 AUG 26. PMID: 40987679.

    Description of Event or Problem · 0

    TITLE: PROSPECTIVE, RANDOMIZED, CONTROLLED CLINICAL STUDY ON SINGLE-INCISION LAPAROSCOPIC CHOLECYSTECTOMY: AN ANALYSIS OF 449 CASES FROM A SINGLE CENTER. THIS STUDY AIMS TO PROVIDE OBJECTIVE EVIDENCE ON THE SAFETY AND EFFICACY OF PERFORMING SILC WITH CONVENTIONAL INSTRUMENTS IN A CHINESE CLINICAL SETTING. 891 PATIENTS WERE RANDOMIZED TO SILC (N = 449(MALE=161)(FEMALE=288) MEAN AGE OF 46.80 PLUS OR MINUS 13.67) OR CLC (N = 442)(MALE=181)(FEMALE=261) MEAN AGE OF 47.71 PLUS OR MINUS 13.60). OPERATIVE PARAMETERS, POSTOPERATIVE RECOVERY, COMPLICATIONS, AND PATIENT-REPORTED OUTCOMES WERE EVALUATED. PRIMARY ENDPOINTS WERE OPERATIVE TIME, BLOOD LOSS, AND COMPLICATION RATES. SECONDARY OUTCOMES INCLUDED HOSPITAL STAY, PAIN SCORES, AND COSMETIC SATISFACTION (VANCOUVER SCAR SCORES). ALL SURGICAL PROCEDURES WERE PERFORMED USING STANDARD LAPAROSCOPIC INSTRUMENTS TO ENSURE REPRODUCIBILITY AND COST- EFFECTIVENESS. SUTURING AND CLOSURE OF THE UMBILICAL INCISION - THE UMBILICAL INCISION WAS SUTURED USING ABSORBABLE SUTURES (4-0 VICRYL, PRODUCT OF ETHICON, USA). BASED ON THE CHARACTERISTICS OF THE WOUND, SKIN SUTURING WAS COMPLETED BY USING INTERMITTENT CONTINUOUS OR UMBILICAL CONTOURING METHODS. FOR SILC PROCEDURE, THE OUTER RING OF THE RETRACTOR IS ATTACHED TO A SURGICAL GLOVE TO FORM A GLOVE PORT, AND PNEUMOPERITONEUM IS ESTABLISHED. CONVENTIONAL LAPAROSCOPIC INSTRUMENTS-INCLUDING A LAPAROSCOPE, A GRASPER, AND OTHER STANDARD TOOLS-ARE THEN INTRODUCED THROUGH THIS PORT IN A PREDETERMINED ORDER. THE GRASPER ELEVATES THE GALLBLADDER FUNDUS ANTERIORLY AND LATERALLY TO HELP EXPOSE THE CYSTIC DUCT. IN CASES WHERE EXPOSURE IS COMPROMISED BY ACUTE CHOLECYSTITIS OR ANATOMICAL VARIATIONS (E.G., ENLARGED LIVER SEGMENTS III OR IVB), A CUSTOM-MADE RETRACTION DEVICE IS USED. A 15-CM 0-SIZE ETHICON COATED VICRYL PLUS SUTURE IS MODIFIED BY TYING A KNOT AT ITS END AND ATTACHING A 10-MM HEM-O-LOK CLIP (HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD., HANGZHOU, P. REPORTED COMPLICATIONS INCLUDE: 4-0 VICRYL (ETHICON), GALL BLADDER PERFORATION (N=41), TREATMENT: DRAINAGE CATHETER FOR SEVERE INFLAMMATION OR A HIGH RISK OF BILE LEAKAGE. BILE DUCT INJURY (N=4), TREATMENT: NOT REPORTED. ADJACENT ORGAN INJURY (N=5), TREATMENT: NOT REPORTED. WOUND INFECTION (N=22), TREATMENT: NOT REPORTED. LONG-TERM PAIN (N=37), TREATMENT: NOT REPORTED. LONG-TERM DIARRHEA (N=64), TREATMENT: NOT REPORTED. INCISIONAL HEMORRHAGE (N=2), TREATMENT: NOT REPORTED. BILE LEAKAGE (N=1), TREATMENT: NOT REPORTED. INCISIONAL HERNIA (N=5), TREATMENT: NOT REPORTED. VICRYL PLUS (ETHICON), GALL BLADDER PERFORATION (N=19), TREATMENT: DRAINAGE CATHETER FOR SEVERE INFLAMMATION OR A HIGH RISK OF BILE LEAKAGE. BILE DUCT INJURY (N=2), TREATMENT: NOT REPORTED. ADJACENT ORGAN INJURY (N=2), TREATMENT: NOT REPORTED. WOUND INFECTION (N=9), TREATMENT: NOT REPORTED. LONG-TERM PAIN (N=15), TREATMENT: NOT REPORTED. LONG-TERM DIARRHEA (N=28), TREATMENT: NOT REPORTED. INCISIONAL HEMORRHAGE (N=1), TREATMENT: NOT REPORTED. INCISIONAL HERNIA (N=3), TREATMENT: NOT REPORTED. IN CONCLUSION, SILC IS A SAFE, EFFECTIVE ALTERNATIVE TO CLC, OFFERING BETTER POSTOPERATIVE RECOVERY AND COSMETIC RESULTS. HOWEVER, PATIENT SELECTION AND SURGICAL EXPERTISE ARE CRUCIAL TO OPTIMIZE OUTCOMES AND MINIMIZE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471025 VICRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention