BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLOC 90

    MDR report key: 24646184 · Received March 19, 2026

    Report

    Report Number
    1219930-2026-01790
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Report Date
    March 19, 2026
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GAM
    UDI-DI
    10884521827516
    PMA / PMN Number
    K100257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: VLOCM0436, VLOC 90 0 VL 22' GS-25, (LOT #A5A1747VY); VLOCM0436, VLOC 90 0 VL 22' GS-25, (LOT #A5A1747VY) 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: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED OF THE OPENED SAMPLES NOTED TWO SUTURES WITH ATTACHED NEEDLES, WITH THE SUTURES FOUND BROKEN AT 18 7/16 INCHES AND 16 5/16 INCHES FROM THE NEEDLE ATTACHMENT POINTS. INSPECTION OF REPRESENTATIVE SAMPLES SHOWED NO DAMAGE TO THE BREATHABLE POUCHES OR FOIL POUCHES, WITH NEEDLES PROPERLY PARKED IN RETAINERS AND SUTURES CORRECTLY WOUND WITHOUT ABNORMALITIES; TACTILE AND MICROSCOPIC EVALUATION ALSO REVEALED NO ISSUES. IT WAS REPORTED THAT WHILE SUTURING, THE SUTURE SNAPPED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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 REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE SUTURE SNAPPED. THE ISSUE HAPPENED TO MULTIPLE SUTURES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706959 VLOC 90 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN SURGICAL VLOCM0436 A5A1747VY 10884521827516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11