BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAP 2MM INTRODUCER

    MDR report key: 5704222 · Received June 7, 2016

    Report

    Report Number
    1320894-2016-00055
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 9, 2016
    Report Date
    August 24, 2016
    Manufacturer
    CONMED CORPORATION
    Product Code
    HET
    UDI-DI
    00653405037340
    PMA / PMN Number
    K943810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FROM THE END-USER FACILITY ON (B)(6) 2017. THE EVALUATION OF THE DEVICE IS IN PROCESS; HOWEVER, HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION. EVALUATION STARTED YET NOT COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE (1) LI-1500 2MM INTRODUCER, WAS RETURNED FOR EVALUATION. THE DISTAL END OF THE NYLON SHEATH HAD BROKEN OFF AND PIECES WERE RETURNED. THE SHEATH EXHIBITED A BRITTLE FRACTURE. NYLON IS CHARACTERISTICALLY FLEXIBLE AND PLIABLE. A ROOT CAUSE INVESTIGATION HAS BEEN INITIATED TO DETERMINE IF CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE REQUIRED. THIS LOT WAS MANUFACTURED ON 09-NOV-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NCR'S AND NO NOTE OF DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO REPORTED BREAKAGE. OF THE LOT CONTAINING (B)(4) UNITS, THERE WAS ONLY THIS COMPLAINT RECEIVED FOR DEVICE BREAKAGE. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF (B)(4) COMPLAINTS CONTAINING (B)(4)DEVICES FOR DEVICE BREAKAGE. DURING THIS SAME 2-YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS REPORTED FAILURE MODE (B)(4) PERCENT. THIS FAILURE MODE IS ADDRESSED IN THE RISK DOCUMENT WITH AN ACCEPTABLE RISK LEVEL. THE MICROLAP INTRODUCERS ARE USED TO ESTABLISH AND MAINTAIN A PNEUMOPERITONEUM IN THE ABDOMEN WHILE PROVIDING ACCESS FOR THE MICROLAP LAPAROSCOPE AND OTHER INSTRUMENTS DURING LAPAROSCOPIC PROCEDURES. TO REDUCE THE RISK OF DEVICE BREAKAGE AND PATIENT INJURY, THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: THIS DEVICE IS PROVIDED STERILE FOR SINGLE USE ONLY. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. DO NOT RE-STERILIZE. DISCARD AFTER USE. THE SITE MUST BE INSPECTED FOR HEMOSTASIS AFTER REMOVING THE INSUFFLATION NEEDLE FROM THE CAVITY. ACCESS 2 INTRODUCERS ARE FOR USE WITHIN 2MM INSTRUMENTS. THE MICROLAP INTRODUCERS ARE SPECIFICALLY DESIGNED FOR USE WITH THE CONMED 15CM INSUFFLATION NEEDLE OR OTHER COMPATIBLE 15CM INSUFFLATION NEEDLES. THE ABILITY TO EFFECTIVELY CLEAN AND RE-STERILIZE THIS SINGLE USE DEVICE HAS NOT BEEN ESTABLISHED AND SUBSEQUENT RE-USE MAY ADVERSELY AFFECT THE PERFORMANCE, SAFETY AND /OR STERILITY OF THE DEVICE.

    Description of Event or Problem · 1

    DURING USE OF A LI-1500, MICROLAP 2MM INTRODUCER IN A LAPAROSCOPIC APPENDECTOMY, THE MICRO INTRODUCER BROKE APART IN THE PATIENT. DUE TO THE VERY SMALL PIECES THAT RESULTED, IT IS UNKNOWN IF ALL PIECES OF THE DEVICE WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE AND NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359375 MICROLAP 2MM INTRODUCER MICRO INTRODUCER HET CONMED CORPORATION 201511091 00653405037340

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other