BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE¿

    MDR report key: 6090536 · Received November 9, 2016

    Report

    Report Number
    3005099803-2016-03335
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INJECTION GOLD PROBE FAILED TO TRANSMIT CURRENT. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED GOLD PROBE REVEALED THE PRODUCT RETURNED DOES NOT HAVE VISUAL DEFECTS. THE ELECTRICAL TEST WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATION. BASED ON ALL GATHERED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON THE THIRD WEEK OF OCTOBER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE INJECTION GOLD PROBE FAILED TO CAUTERIZE. A SECOND INJECTION GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME GENERATOR AND GENERATOR SETTINGS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON THE THIRD WEEK OF (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE INJECTION GOLD PROBE FAILED TO CAUTERIZE. A SECOND INJECTION GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME GENERATOR AND GENERATOR SETTINGS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739496 INJECTION GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150 18408364

    Patients

    Seq Age Sex Outcome Treatment
    1