BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - POLYS

    MDR report key: 24362194 · Received February 17, 2026

    Report

    Report Number
    9612501-2026-00411
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 2, 2026
    Report Date
    February 17, 2026
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OROPHARYNGEAL FREE FLAP INSET WITH A SINGLE PORT ROBOT: A CASE SERIES: DANIEL MURARIU, MICROSURGERY, 2026; 46: E70178 HTTPS://DOI.ORG/10.1002/MICR.70178 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 RETROSPECTIVE REVIEW OF ROBOTIC FREE FLAP INSET FOLLOWING TRANSORAL ROBOTIC SURGERY USING THE SINGLE PORT ROBOT FROM 2021 TO 2022. AFTER RESECTION, THE FLAP WAS SUTURED BEGINNING AT THE BASE OF THE TONGUE WITH 3¿0 SUTURE. THE FLAP WAS BROUGHT INTO THE INTRAORAL CAVITY AND THE PEDICLE BROUGHT OUT TO THE NECK WITH THE HELP OF A PENROSE DRAIN. SEVERAL STAY SUTURES WERE PLACED ON THE FLAP TO THE DEFECT EDGES. THE RETRACTOR WAS REPLACED AND THE ROBOT WAS POSITIONED WITH THE CAMERA PLACED IN ¿COBRA¿ POSITION. FLAP INSET BEGAN AT THE BASE OF THE TONGUE WITH 3¿0 SUTURE. THERE WERE 5 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED HEMATOMA IN ONE PATIENT REQUIRING REOPERATION FOR LIGATION OF A SMALL BLEEDER BETWEEN THE TONGUE AND FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423293 UNKNOWN - POLYS SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN - POLYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention