BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPORT+

    MDR report key: 4491528 · Received January 29, 2015

    Report

    Report Number
    9616720-2015-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 12, 2015
    Report Date
    January 19, 2015
    Manufacturer
    ADVANCED SURGICAL CONCEPTS, LTD
    Product Code
    OTJ
    PMA / PMN Number
    K110004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) REFERENCED IN THIS REPORT HAVE NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED AT THIS TIME. WHEN ADDITIONAL INFORMATION, SUCH AS EVALUATION OF TESTING ON RETAIN IS AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ASC (ADVANCES SURGICAL CONCEPTS) WAS INFORMED BY (B)(4), THE DISTRIBUTOR, THAT DEVICE LEADED CO2 DURING AN UNSPECIFIED PROCEDURE. IT WAS STATED; "THAT CO2 STARTING LEAKING AFTER THE FIRST OVARY AND FALLOPIAN TUBE WERE DISSECTED. ABDOMEN DEFLATED PER DOCTOR AND ASK FOR SECOND TRIPORT. SECOND TRIPORT LEAKED CO2 AS WELL - DOCTOR ASKED FOR THIRD TRIPORT WHICH DID NOT LEAK. DOCTOR THOUGHT THE OVARY AND FALLOPIAN TUBE WAS STILL IN THE PATIENT'S ABDOMEN. DOCTOR SEARCHED AND OVARY WAS FOUND IN FIRST TRIPORT. DOCTOR EXPLAINED THAT IT MUST HAVE BEEN SUCKED UP WHEN THE CO2 WAS LOST DUE TO MALFUNCTION OF THE DEVICE." THERE WAS NO INFORMATION REGARDING THE PATIENT'S CONDITION. IT IS UNCLEAR AS TO THE NATURE OF THE MALFUNCTION AND HOW OR WHY THIS OCCURRED LATE IN THE PROCEDURE. IT IS NOT CLEAR IF THE DEVICE LEAKS ARE DUE TO DEVICE MALFUNCTION OR ABNORMAL USE. ASC FOLLOWED UP WITH THE USER FACILITY BY EMAIL AND TELEPHONE AS WAS INFORMED BY EMAIL THAT THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS A BILATERAL SALPINGO-OOPHORECTOMY. IT WAS CONFIRMED THAT IT WAS THE DISSECTED OVARY THAT WAS LOCATED IN THE FIRST DEVICE. THE ISSUE HAS BEEN IDENTIFIED AS A "LEAK OR LOSS OF SEAL AT BOOT." THIS INFORMATION IS HELPFUL AS IT IDENTIFIES THE COMPONENT THAT WAS INVOLVED IN THE REPORTED EVENT BUT IT IS STILL UNCLEAR WHAT ACTUALLY OCCURRED. THE DEVICE IS DESIGNED SO THAT THE BOOT ASSEMBLY COMPONENT MAY BE DETACHED AND REATTACHED TO THE RETRACTOR BASE COMPONENT AS REQUIRED TO ALLOW FOR TISSUE EXTRACTION. ON (B)(6) 2015, ASC SPOKE DIRECTLY WITH PHYSICIAN. HE EXPLAINED THAT THE RETRACTABLE SLEEVE HAD COME OUT OF THE OUTER PROXIMAL RING DURING THE PROCEDURE THAT RESULTED IN THE LOSS OF PNEUMOPERITONEUM. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. HE WENT ON TO EXPLAIN THAT HE HAS USED 600-800 DEVICES AND NEVER ENCOUNTERED THIS ISSUE BEFORE. FURTHERMORE HE DESCRIBED THE CORRECT SET UP OF THE DEVICE AS PER THE IFU WHICH WOULD HAVE BEEN PREVENTED MOVEMENT OF THE SLEEVE. NEITHER ASC OR THE PHYSICIAN COULD DETERMINE THE CAUSE AT THIS TIME. ASC WILL CONDUCT TESTING ON A RETAIN FROM THE LOT TO TRY AND RECREATE THE INCIDENT TO DETERMINE THE ROOT CAUSE, RISK MANAGEMENT FILES WILL BE REVIEWED AS APPROPRIATE. ASC WILL DISCUSS FINDINGS WITH THE PHYSICIAN. A SALES REP HAS REQUESTED TO ATTEND THE PHYSICIAN'S NEXT CLINICAL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66670 TRIPORT+ LAPAROSCOPIC ACCESS DEVICE OTJ ADVANCED SURGICAL CONCEPTS, LTD WA58010T 108791

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR