BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX*ACCESS 55MM ART STAP THIC

    MDR report key: 1902771 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06596
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED: WERE THE COLORED DRIVERS IN THE CARTRIDGE VISIBLE? WE HAVE NO DETAILED INFORMATION. WAS THE TISSUE EXCISED PRIOR TO THE STAPLE LINE BEING EXAMINED? NO. THE DOCTOR NOTED THE STAPLES WERE NOT DEPLOYED AFTER CUTTING THE TISSUE. ALTHOUGH THERE WAS SLIGHTLY BLOOD LOSS, THE BLEEDING WAS CONTROLLED WITH GAUZE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. WAS A LEAK TEST PERFORMED OR WAS THE STAPLE INSUFFICIENCY DETECTED VISUALLY? WE HAVE NO DETAILED INFORMATION. BUT THE DOCTOR COMMENTED THAT THE DEVICE DID NOT HAVE A DIFFICULTY IN CLOSING AND THEN THE FIRING TRIGGER WAS GRASPED COMPLETELY DURING THE OPERATION.

    Additional Manufacturer Narrative · 1

    (B)(4). OPEN HANDLE SEAM THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE ARRIVED WITH THE HANDLES OPEN BY THE SEAM AND VOID OF STAPLES. THE DEVICE WAS MANUALLY LOADED WITH STAPLES AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS FIRED AND IT FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE HANDLES BECAME OPEN, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) . IT SHOULD ALSO BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SURGICAL PROCEDURE, THE STAPLES WERE NOT DEPLOYED AT THE FIRING. THE TISSUE WAS A LITTLE THICK. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED AS FOLLOWS: EVEN MALFORMED STAPLES WERE NOT DEPLOYED. IT HAD NO DIFFICULTY IN FIRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WAS PREPPED NO PROBLEMS NOTED. 50% CONTRAST RATIO WAS USED. A 6F, 45CM NON-BSC SHEATH WAS USED TO GAIN ACCESS VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0X60/80 4F STERLING BALLOON WAS ADVANCED OVER A 0.018 NON-BSC GUIDE WIRE TO THE LESION WITH NO RESISTANCE NOTED AND THE BALLOON WAS INFLATED COMPLETELY AND WITHOUT DIFFICULTY USING A 2ML LUER LOCK SYRINGE. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, BUT THE BALLOON FAILED TO DEFLATE. THE DEVICE WAS THEN PULLED BACK FULLY INFLATED INTO THE END OF THE SHEATH, AND BOTH THE SHEATH AND BALLOON CATHETER WERE REMOVED TOGETHER. IT WAS NOTED THAT THE SHAFT OF THE DEVICE WAS KINKED AND STRETCHED. ONCE REMOVED OUTSIDE THE PATIENT, IT WAS STILL NOT POSSIBLE TO DEFLATE THE BALLOON. A NEW SHEATH WAS INSERTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX*ACCESS 55MM ART STAP THIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1