BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAONE

    MDR report key: 19760807 · Received July 17, 2024

    Report

    Report Number
    9612501-2024-01734
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    April 5, 2024
    Report Date
    September 15, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GCJ
    UDI-DI
    10884521657687
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: D4 (EXPIRATION DATE, LOT#) D9, G3, H3, H4, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. FUNCTIONAL TESTING FOUND THAT THE OBTURATOR WAS REMOVED AND THE CIRCULAR SEAL AND DUCKBILL SEAL WERE STRETCHED OUT. THE DEVICE FAILED AN AIR LEAK TEST. THE PRODUCT WAS SHIPPED BACK WITH THE OBTURATOR INSERTED IN THE CANNULA AND THEREFORE THE LENGTH OF TIME IT WAS INSERTED DURING SHIPMENT MAY HAVE ALSO RESULTED IN THE STRETCHED SEALS. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. (255 MAX - 245 MIN), THE MEASUREMENTS WITH CALIPERS WERE, 251, 250, 248, 253, 251, 251. IT WAS REPORTED THAT THE SEAL HAS DAMAGED AND LEAKS. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN CONTACT IS MADE WITH A SURGICAL INSTRUMENT DURING CLINICAL APPLICATION. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: USE SPECIAL CARE WHEN INTRODUCING OR REMOVING SHARP-EDGED OR SHARP-ANGLED ENDOSCOPIC INSTRUMENTS TO MINIMIZE THE POTENTIAL OF INADVE RTENT DAMAGE TO THE SEAL. 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, DURING LAPAROSCOPY, WHEN THE TROCAR WAS PASSING THE CLIP THE INTERNAL VALVE OF THE TROCAR RUPTURED CAUSING LEAKAGE OF PNEUMOPERITONEUM. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143213 VERSAONE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ DAVIS & GECK CARIBE LTD ONB12STF J3A0761Y 10884521657687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male