BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 10870220 · Received November 19, 2020

    Report

    Report Number
    2210968-2020-09136
    Event Type
    Death
    Date Received
    November 19, 2020
    Date of Event
    January 1, 2019
    Report Date
    October 27, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). 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. CITATION: SURGERY SCIENCE 2019; 3(1): 349-353. HTTPS://DOI.ORG/10.33545/SURGERY.2019.V3.I1F.59. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS (NO DEATH) SUBMITTED VIA 2210968-2020-09132. EVENTS (DEATH) WAS SUBMITTED VIA 2210968-2020-09136.

    Description of Event or Problem · 1

    TUBE CAECO-ILEOSTOMY WITH REPAIR: AN INNOVATIVE SURGICAL TECHNIQUE FOR TYPHOID PERFORATION. THE AIM OF THIS RETROSPECTIVE STUDY IS TO DESCRIBE AN INNOVATIVE SURGICAL TECHNIQUE ¿TUBE CAECO-ILEOSTOMY WITH REPAIR OF PERFORATION¿ FOR PATIENTS WITH TYPHOID PERFORATION PRESENTING IN RESOURCE LIMITED SET-UP. BETWEEN MAY 1997 AND APR 2017, 68 PATIENTS WITH TYPHOID ILEAL PERFORATION UNDERWENT LAPAROTOMY WITH ¿TUBE CAECO ILEOSTOMY AND REPAIR OF THE PERFORATION¿. THE SMALL GUT WAS EXAMINED IN ITS ENTIRE LENGTH AND THE PERFORATION WAS SEARCHED AND LOCATED. FIRST THREE SEROMUSCULAR SUTURES IN POSTERIOR CAECAL WALL AND PARITY OF THE ABDOMEN WAS TAKEN BY 2-0 MERSILK (ETHICON). THEN A CURVED LONG ARTERY FORCEP WAS INSERTED THROUGH THE PERFORATION AND PASSED UP TO THE CAECUM. THEN A CAECOSTOMY WAS DONE AT THE TIP OF THE ARTERY FORCEP AND IT WAS PUSHED OUT THROUGH IT AND THE POSTERIOR LAYER OF THE SUTURE WAS TIED. THE CAECUM WAS FURTHER FIXED TO THE PARIETAL WITH 3 OR 4 INTERRUPTED MERSILK 2-0 STITCHES (ETHICON) ANTERIOR TO THE CAECOSTOMY SO THAT IT GETS ADHERED TO THE PARITY. THEN A CORE OF TISSUE WAS TAKEN FOR BIOPSY FROM THE PERFORATION SITE AND IT WAS REPAIRED IN TWO LAYERS WITH 3-0 SILK SUTURES. POST-OPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N=20); WOUND DEHISCENCE (N=14); RESIDUAL ABSCESS (N=6); SEPTICEMIA (N=14) OF WHICH 2 OF THESE PATIENTS DIED; FAECAL FISTULA (N=3); AND POST-OPERATIVE INCISIONAL HERNIA (N=5). THE FAECAL FISTULA HEALED SPONTANEOUSLY WITH CONSERVATIVE TREATMENT. TUBE CAECO ILEOSTOMY METHOD SUPPORTED BY GOOD PERITONEAL TOILETING AND ANTI-TYPHOID CHEMOTHERAPY SHOWS GOOD RESULTS WITH RESPECT TO HEALING AND LESS POST-OPERATIVE COMPLICATIONS WHICH ARE VERY COMMON IN CASES OF TYPHOID ILEAL PERFORATION. THE ENCOURAGING RESULTS WITH THIS PROCEDURE STRONGLY ADVOCATE FURTHER STUDIES AT OTHER CENTERS. THIS METHOD CAN BE ADOPTED IN MULTIPLE INJURIES OF ILEUM DUE TO TRAUMA ALSO AS EVERY CENTIMETER OF ILEUM HAS IMPORTANCE IN ABSORPTION OF NUTRIENTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330714 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death