BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 21918373 · Received April 28, 2025

    Report

    Report Number
    1219930-2025-01971
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 28, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMET SAHIN, KERIM GÜZEL; GLYCEMIC CONTROL IN OBESE TYPE 2 DIABETIC PATIENTS TREATED WITH LAPAROSCOPIC SLEEVE GASTRECTOMY AND TRANSIT BIPARTITION; SAMET SAHIN, 2025, MEDICAL SCIENCE MONITOR; SURGICAL TECHNIQUE AND GLYCEMIC CONTROL AFTER LSG+TB © MED SCI MONIT, 2025; 31: E947047. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY THAT ANALYZED OBESE TYPE 2 DIABETES MELLITUS PATIENTS WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY WITH TRANSIT BIPARTITION BETWEEN MAY 2015 AND MAY 2019, A RELOAD WAS USED TO DIVIDE THE STOMACH AND A 46F OROGASTRIC TUBE WAS USED. THE STAPLE LINE WAS ROUTINELY SUTURED WITH AN UNSPECIFIED SUTURE, COVERING THE ENTIRE STAPLED LINE FROM TOP TO BOTTOM. THE STAPLER WAS THEN USED TO TRANSECT THE SMALL INTESTINE AND PERFORM THE ANASTOMOSIS. RESIDUAL ANASTOMOSIS GAPS WERE CLOSED WITH AN UNSPECIFIED SUTURE. THERE WERE 420 PATIENTS IN THE STUDY AND SERIOUS POSTOPERATIVE COMPLICATIONS WERE OBSERVED ON 22 PATIENTS WHICH INCLUDED: ANASTOMOTIC LEAKS WHICH WERE TREATED WITH PIGTAIL DRAINAGE OR REOPERATION; INTRA-ABDOMINAL ABSCESS WHICH WAS MANAGED WITH PERCUTANEOUS DRAINAGE; GASTRO-JEJUNAL STRICTURES WHICH WERE MANAGED VIA BALLOON DILATATION OR LAPAROSCOPIC REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595868 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention