BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II 9C

    MDR report key: 5480518 · Received March 4, 2016

    Report

    Report Number
    2248146-2016-00021
    Event Type
    Injury
    Date Received
    March 4, 2016
    Report Date
    January 30, 2018
    Manufacturer
    DATASCOPE CORP.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015, Z-1462-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE REC'D BY MFR DATE DATE WAS NOT ENTERED IN THE INITIAL MDR. DATE REC'D BY MFR DATE DATE: 02/04/2016.

    Description of Event or Problem · 0

    (B)(4). EVENT DESCRIPTION FOR MDR, "THIS SURGEON INSTALLED A 9 PIN TIGERPAW TP15AJ09 AND THEY HAD BLEEDING THAT HAD TO BE REPAIRED WITH STITCHES. AN ATRICURE REP IN THE PROCEDURE SAID THESE ITEMS HAD BEEN RECALLED LAST YEAR. THE CUSTOMER WAS SURPRISED AT THIS, THAT SHE HAD NOT BEEN NOTIFIED. I HAVE SINCE CONFIRMED WITH (B)(4) THAT BACK IN (B)(6) 2015 DURING THE FIELD ACTION THAT THEY DID NOT HAVE ANY REMAINING UNITS, THE RECALL FORM WAS SIGNED BY (B)(4), SUPPLY CHAIN DIRECTOR." THIS SURGEON INSTALLED A 9 PIN TIGERPAW TP15AJ09 AND THEY HAD BLEEDING THAT HAD TO BE REPAIRED WITH STITCHES. AN ATRICURE REP IN THE PROCEDURE SAID THESE ITEMS HAD BEEN RECALLED LAST YEAR. THE CUSTOMER WAS SURPRISED AT THIS, THAT SHE HAD NOT BEEN NOTIFIED. I HAVE SINCE CONFIRMED WITH (B)(4) THAT BACK IN (B)(6) 2015 DURING THE FIELD ACTION THAT THEY DID NOT HAVE ANY REMAINING UNITS, THE RECALL FORM WAS SIGNED BY (B)(4), SUPPLY CHAIN DIRECTOR.

    Additional Manufacturer Narrative · 1

    ON 03/04/2016 08:56 AM (GMT-5:00) ADDED BY (B)(6): THIS PRODUCT IS NOT CURRENTLY BEING MANUFACTURED. IT WAS ORIGINALLY MANUFACTURED/REGISTERED BY FACILITY (B)(4) WHICH IS NO LONGER A REGISTERED FACILITY. RECALLED MEDICAL DEVICE TIGERPAW SYSTEM II WAS USED, CUSTOMER WAS NOTIFIED OF RECALL. THE CONFIRMATION (MEDICAL DEVICE RECALL (REMOVAL) RESPONSE FORM) THAT THE CUSTOMER HAS NO REMAINING UNITS WAS RECEIVED ON (B)(6) 2015. ON 03/03/2016 05:08 PM (GMT-5:00) ADDED BY (B)(6): THIS PRODUCT IS NOT CURRENTLY BEING MANUFACTURED. IT WAS ORIGINALLY MANUFACTURED/REGISTERED BY FACILITY (B)(4) WHICH IS NO LONGER A REGISTERED FACILITY. RECALLED MEDICAL DEVICE TIGERPAR SYSTEM II WAS USED, CUSTOMER WAS NOTIFIED OF RECALL. THE CONFIRMATION (MEDICAL DEVICE RECALL (REMOVAL) RESPONSE FORM) THAT THE CUSTOMER HAS NO REMAINING UNITS WAS RECEIVED ON (B)(6) 2015. THE DEVICE HAS BEEN REQUESTED FOR RETURN. IF IT BECOMES AVAILABLE FOR EVALUATION A SUPPLEMENTAL REPORT WITH THE RESULTS OF THE EVALUATION WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    ON 03/04/2016 08:55 AM (GMT-5:00) ADDED BY (B)(6): INTRAOPERATIVE BLEEDING AFTER THE TIGERPAW II MEDICAL DEVICE WAS USED. STITCHES WERE USED TO STOP THE BLEEDING. THERE WAS NO KNOWN NEGATIVE PATIENT OUTCOME. ON 03/03/2016 05:13 PM (GMT-5:00) ADDED BY (B)(6) INTRAOPERATIVE BLEEDING AFTER THE TIGERPAW II MEDICAL DEVICE WAS USED. STITCHED WERE USED TP STOP THE BLEEDING. THERE WAS NO KNOWN NEGATIVE PATIENT OUTCOME. ON 03/03/2016 04:53 PM (GMT-5:00) ADDED BY (B)(6): EVENT DESCRIPTION FOR MDR, "THIS SURGEON INSTALLED A 9 PIN TIGERPAW TP15AJ09 AND THEY HAD BLEEDING THAT HAD TO BE REPAIRED WITH STITCHES. AN ATRICURE REP IN THE PROCEDURE SAID THESE ITEMS HAD BEEN RECALLED LAST YEAR. THE CUSTOMER WAS SURPRISED AT THIS, THAT SHE HAD NOT BEEN NOTIFIED. I HAVE SINCE CONFIRMED WITH (B)(6) THAT BACK IN (B)(6) 2015 DURING THE FIELD ACTION THAT THEY DID NOT HAVE ANY REMAINING UNITS, THE RECALL FORM WAS SIGNED BY (B)(6), SUPPLY CHAIN DIRECTOR." THIS SURGEON INSTALLED A 9 PIN TIGERPAW TP15AJ09 AND THEY HAD BLEEDING THAT HAD TO BE REPAIRED WITH STITCHES. AN ATRICURE REP IN THE PROCEDURE SAID THESE ITEMS HAD BEEN RECALLED LAST YEAR. THE CUSTOMER WAS SURPRISED AT THIS, THAT SHE HAD NOT BEEN NOTIFIED. I HAVE SINCE CONFIRMED WITH (B)(6) THAT BACK IN (B)(6) 2015 DURING THE FIELD ACTION THAT THEY DID NOT HAVE ANY REMAINING UNITS, THE RECALL FORM WAS SIGNED BY BRANDON MILLER, SUPPLY CHAIN DIRECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136025 TIGERPAW SYSTEM II 9C STAPLE, IMPLANTABLE GDW DATASCOPE CORP. TP15AJ09 1201M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention