BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROTACK

    MDR report key: 25323069 · Received May 28, 2026

    Report

    Report Number
    2647580-2026-01525
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    October 15, 2025
    Report Date
    May 28, 2026
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ISMAIL BIYIKS, SENER GEZER, SEMANUR KARATAS, GEORGIOS GRIGORIADIS. "COMPARISON OF SURGICAL OUTCOMES OF MESH PLACEMENT ANTERIOR VERSUS POSTERIOR TO THE CERVIX UTERI IN LAPAROSCOPIC PECTOPEXY WITH UTERINE PRESERVATION, 2025." INTERNATIONAL UROGYNECOLOGY JOURNAL (2025) 37:749¿755. HTTPS://DOI.ORG/10.1007/S00192-025-06382-W. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6 ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 PERFORMED BETWEEN JANUARY 2022 AND DECEMBER 2023 TO COMPARE THE OUTCOMES OF LAPAROSCOPIC PECTOPEXY (LP) WITH UTERINE PRESERVATION BETWEEN MESH PLACEMENT ANTERIOR TO THE CERVIX UTERI AND MESH PLACEMENT POSTERIOR TO THE CERVIX UTERI, 48 WOMEN HAD MESH PLACEMENT ANTERIOR TO THE CERVIX (GROUP I) AND 24 WOMEN WITH MESH PLACEMENT POSTERIOR TO THE CERVIX (GROUP II). WITHIN THE FIRST SIX DAYS POSTOPERATIVELY, SIX RELAPSES WERE OBSERVED IN GROUP I AND TWO RELAPSES WERE OBSERVED IN GROUP II. IN ALL RELAPSES, CYSTOCELE WAS OBSERVED IN ADDITION TO APICAL PROLAPSE. TWO PATIENTS IN EACH GROUP REQUIRED LAPAROSCOPIC SACROCOLPOPEXY (LS) WITH SIMULTANEOUS CYSTOCELE REPAIR. IT WAS FOUND THAT THE MESH HAD SEPARATED FROM THE CERVIX IN GROUP I, WHEREAS THE MESH HAD SEPARATED FROM THE PECTINEAL LIGAMENTS IN GROUP II. ALL PATIENTS WERE DISCHARGED WITHIN 48 HOURS.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2022 AND DECEMBER 2023 TO COMPARE THE OUTCOMES OF LAPAROSCOPIC PECTOPEXY (LP) WITH UTERINE PRESERVATION BETWEEN MESH PLACEMENT ANTERIOR TO THE CERVIX UTERI AND MESH PLACEMENT POSTERIOR TO THE CERVIX UTERI, 48 WOMEN HAD MESH PLACEMENT ANTERIOR TO THE CERVIX (GROUP I) AND 24 WOMEN WITH MESH PLACEMENT POSTERIOR TO THE CERVIX (GROUP II). WITHIN THE FIRST SIX DAYS POSTOPERATIVELY, SIX RELAPSES WERE OBSERVED IN GROUP I AND TWO RELAPSES WERE OBSERVED IN GROUP II. IN ALL RELAPSES, CYSTOCELE WAS OBSERVED IN ADDITION TO APICAL PROLAPSE. TWO PATIENTS IN EACH GROUP REQUIRED LAPAROSCOPIC SACROCOLPOPEXY (LS) WITH SIMULTANEOUS CYSTOCELE REPAIR. IT WAS FOUND THAT THE MESH HAD SEPARATED FROM THE CERVIX IN GROUP I, WHEREAS THE MESH HAD SEPARATED FROM THE PECTINEAL LIGAMENTS IN GROUP II. ALL PATIENTS WERE DISCHARGED WITHIN 48 HOURS. THE ADVERSE EVENT WAS NOT RELATED TO THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545993 UNKNOWN PROTACK ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN UNKNOWN PROTACK

    Patients

    Seq Age Sex Outcome Treatment
    1