BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER

    MDR report key: 25082633 · Received May 5, 2026

    Report

    Report Number
    2647580-2026-01326
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    November 13, 2025
    Report Date
    May 5, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K151356
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JI-YEON MUN, NINA YOO, BONG-HYEON KYE; HERNIA; 2026;FROM HANDS TO HANDLES: A MODERN DUEL BETWEEN LAPAROSCOPIC TEP AND ROBOTIC TAPP;1 0.1007/S10029-025-03537-Y 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 THE LITERATURE, A RETROSPECTIVE STUDY COMPARED OUTCOMES OF LAPAROSCOPIC TOTALLY EXTRAPERITONEAL AND ROBOTIC TRANSABDOMINAL PREPERITONEAL IN 332 PATIENTS WHO UNDERWENT INGUINAL HERNIA SURGERY BETWEEN APRIL 2021 AND DECEMBER 2023. IN THE LAPAROSCOPIC GROUP, AFTER MAKING AN INCISION, EITHER A SPACE MAKER PRO OR CAMERA DISSECTION WAS PERFORMED, FOLLOWED BY ADDITIONAL DISSECTION AND PLACEMENT OF MESH. AFTER MATCHING, THERE WERE 67 PATIENTS IN EACH GROUP. COMPLICATIONS IN THE LAPAROSCOPIC GROUP INCLUDED: PERITONEUM OR SAC TEARING, MINOR BLEEDING, HEMATOMA, SEROMA, WOUND COMPLICATION AND WOUND PAIN. CONVERSION TO EITHER ANOTHER TECHNIQUE OR AN OPEN PROCEDURE OCCURRED IN THREE PATIENTS. NO ADDITIONAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361732 SPACEMAKER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN UNK SPACEMAKER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention