BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARRETT-OSSOFF-PILLING LARYN 25MM X 19CM

    MDR report key: 6862966 · Received September 13, 2017

    Report

    Report Number
    3011137372-2017-00287
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 29, 2017
    Report Date
    August 29, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DHR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 522196. (2) SAMPLES OF PC12-02846 LOT 5/2016 WERE RECEIVED FOR EVALUATION. PC12-02846 IS A CUSTOM PILLING SCOPE WHICH WAS MANUFACTURED TO THE CUSTOMER'S SPECIFICATIONS. THIS DESIGN HAS SINCE BEEN CONVERTED TO MARKETABLE PART NUMBER WITH INVENTORY. ALTHOUGH THE PART NUMBERS ARE DIFFERENT THE PHYSICAL DEVICE IS IDENTICAL TO 522196. THIS COMPLAINT IS LINKED TO 20023015. BOTH SAMPLES WAS INVESTIGATED TOGETHER. 1 OF 2 SAMPLES HAS BEEN PREVIOUSLY REPAIRED BY A 3RD PARTY SERVICE. THE SOLDER ON THE REPAIRED SCOPE IS EXCESSIVE. THE MAIN CHANNEL OF THE SCOPES EXHIBIT SCRAPES ALONG THE SOLDER. THE FILLER METAL HAS BEEN SEVERELY DISTORTED IN THESE AREAS. ADDITIONALLY THE LIGHT CARRIERS ARE BENT OUT OF ALIGNMENT. NO PARTICULATE WAS NOTED ON OR IN THE DEVICE. BASED ON THE CONDITION OF THESE INSTRUMENTS IT IS LIKELY THAT THE METAL PARTICULATE ORIGINATED FROM THE FILLER METAL ON THE EXTERNAL SURFACES OF THE SCOPE. THESE SCRAPES ARE CONSISTENT WITH DAMAGE FROM TEETH. THE REPAIR PROCESS MAY HAVE ALSO CONTRIBUTED TO THE PARTICULATE. IT SHOULD BE NOTED THAT THESE INSTRUMENTS HAVE BEEN IN USE FOR AT LEAST A YEAR OTHER REMARKS: WITHOUT REPORTED INCIDENT. ANY PARTICULATE THAT WAS OBSERVED ORIGINATED FROM THE CUSTO MER'S CLEANING AND/OR USE OF THE DEVICE. THE SAMPLES WERE URGENTLY RETURNED AT THE CUSTOMER'S REQUEST AND ARE NO LONGER AVAILABLE FOR REVIEW. SEVERAL WIPES WERE USED TO SAMPLE THE INTERIOR AND EXTERIOR SURFACES FOR LOOSE METAL PARTICLES - NO CONCERNS WERE NOTED. STOCK CHECKS FOUND NO EVIDENCE OF PARTICULATE IN INVENTORY. METHOD OF USE RELATED - SITE SPECIFIC FAILURE.

    Description of Event or Problem · 1

    METAL SHARDS WERE COMING OFF THE INSTRUMENT. A METAL SHARD DID FALL INTO THE PATIENT BUT THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. NO HARM WAS DONE TO THE PATIENT.

    Description of Event or Problem · 1

    METAL SHARDS WERE COMING OFF THE INSTRUMENT. A METAL SHARD DID FALL INTO THE PATIENT BUT THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643747 GARRETT-OSSOFF-PILLING LARYN 25MM X 19CM CAL TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1