BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO NON-ABSORBABLE SURGICAL SUTURES

    MDR report key: 2102861 · Received May 3, 2011

    Report

    Report Number
    3004365956-2011-00187
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO INVESTIGATE. EVALUATION METHOD: DHR REVIEW WAS PERFORMED. RESULTS: THE DHR REVIEW REVEALED THAT NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THE COMPLAINT REPORTED. CONCLUSIONS: NO CONCLUSION CAN BE ESTABLISHED BASED ON THE LACK OF SAMPLE. NO CORRECTIVE ACTION WAS TAKEN.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THIS ISSUE WAS REPORTED AS FOLLOWS: "DURING A RICHTER PROCEDURE, THE PHYSICIAN USED A CAPIO + A NEEDLE, BUT INSIDE THE PATIENT, THE NEEDLE DETACHED FROM THE WIRE AND WAS LOST. SO FAR, THE NEEDLE WASN'T RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO NON-ABSORBABLE SURGICAL SUTURES CAPIO SURGICAL SUTURE GCJ TELEFLEX MEDICAL NA 02H1001830

    Patients

    Seq Age Sex Outcome Treatment
    1