BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 11961919 · Received June 8, 2021

    Report

    Report Number
    2936999-2021-00522
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 17, 2021
    Report Date
    August 20, 2021
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GCJ
    UDI-DI
    10884521704046
    PMA / PMN Number
    K163102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE DEVICE WAS CUT WITH LITTLE OR NO STRETCH DEFORMATION ALONG THE CUTLINE. IT WAS ALSO NOTED THAT THERE WAS PROPER WELDING AT THE DISTAL END. IT WAS REPORTED THAT THE BAG PARTIALLY DETACHED FROM THE RING AND OR TIME WAS EXTENDED BY GREATER THAN 30 MINUTES RESULTING FROM PRODUCT FAILURE. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE CAN OCCUR IF THE SPECIMEN POUCH CONTACTS A SHARP OBJECT AND SUBSEQUENTLY RIPS UNDER TENSION. 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, THE BAG PARTIALLY DETACHED FROM THE RING. THE DEVICE COULD NOT BE RETRACTED INTO THE SHAFT AND THIS AFFECTED THE SUCCESSFUL INSERTION INTO TROCAR. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES BUT THERE WAS NO ADVERSE REACTION. A NEW BAG WAS USED WHICH WORKED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851231 RELIACATCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CELESTICA ELECTRONICS S PTE LTD CATCH10 C1110820A 10884521704046

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR