BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMRX

    MDR report key: 1881665 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04442
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE BLUE PAINT BAND AT THE TIP WAS FOUND PEELED/FLAKED. NO FURTHER DAMAGE WAS OBSERVED AT THE TIP. ADDITIONALLY, NO DAMAGE WAS NOTED TO THE WORKING LENGTH OR THE REMAINING PAINT BANDS. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DISTAL END WAS TORN. THE BLUE COATING WAS FOUND TO HAVE PEELED, HOWEVER, NO TEAR WAS OBSERVED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED FOR PAINT INTEGRITY SO THE FLAKING LIKELY OCCURRED DUE TO CONTACT WITH THE ENDOSCOPE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THIS EVENT HAS BEEN DEEMED A NON MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE DISTAL END WAS NOT TORN.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS NOT KNOWN. HOWEVER, HE WAS NOTED TO BE IN HIS (B)(6). PATIENT'S EXACT WEIGHT IS NOT KNOWN. HOWEVER, IT WAS NOTED TO BE APPROXIMATELY (B)(6). 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, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ADVANCING THE DEVICE THROUGH THE SCOPE, THE BLUE PAINT ON THE DISTAL TIP WAS PEELING AND THE DISTAL END BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED IN THE COMMON BILE DUCT DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, WHILE ADVANCING THE DEVICE THROUGH THE SCOPE, THE BLUE PAINT ON THE DISTAL TIP WAS PEELING AND THE DISTAL END BECAME TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMRX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - SPENCER M00545770 0013509630

    Patients

    Seq Age Sex Outcome Treatment
    1