BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 2071055 · Received April 27, 2011

    Report

    Report Number
    3005075853-2011-01753
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EES QUALITY ENGINEER REVIEWED RETURNED PHOTOGRAPHS AND COMMENTED AS FOLLOWS: THE STAPLES OBSERVED APPEARED TO BE ACCEPTABLE "B" SHAPES. NOTED ONE FULLY FORMED STAPLE THAT APPEARED TO BE JUST SITTING ON TISSUE, BUT OTHERS THAT COULD BE SEEN APPEARED TO BE SECURED IN TISSUE. THE PHOTOGRAPHS APPEAR TO SHOW AN OFF CENTER CUT WITH POSSIBLE TISSUE IMBALANCE. HOWEVER, GIVEN THIS TYPE PROCEDURE, IT IS NOT NECESSARILY UNCOMMON TO HAVE AN IMBALANCED TISSUE SITUATION. EES DESIGN ENGINEER COMMENTED AS FOLLOWS: FROM THE INFORMATION PROVIDED, IT SOUNDS LIKE THEY HAD PROBLEMS PURSE STRINGING THE HEMORRHOIDAL TISSUE. AS FAR AS THE STAPLE MIGRATION, IT MAY BE POSSIBLE IN MUCOSAL TISSUE IN THE 5 TO 9 DAY TIME SPAN, BUT I WILL DEFER TO DR. (B)(4) ON THAT MATTER. EES CONSULTANT SURGEON REVIEWED RETURNED PHOTOGRAPHS AND COMMENTED AS FOLLOWS: AGREES WITH BOTH ENGINEERS. IT WOULD NOT BE A SURPRISE TO HAVE FREE FLOATING STAPLES AT THAT TIME FRAME. DOES NOT BELIEVE IT IS CONTRIBUTING TO THE PATIENT'S CURRENT SYMPTOMS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL SURGICAL PROCEDURE. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED ON (B)(4) 2011: SEVERAL CLIPS WERE RELEASED FROM TISSUE. WE DON'T KNOW IF THE FOLLOW UP VISITS WERE PREVIOUSLY SCHEDULED. ON (B)(6), IT WAS JUST A FOLLOW UP VISIT, NOTHING WAS DONE TO OR FOR THE PATIENT. THE PATIENT WAS REHOSPITALIZED FOR PAIN AND BECAUSE THE COLONOSCOPY EXAMINATION SHOWED THAT SEVERAL STAPLES WERE RELEASED FROM TISSUE. THE SURGEON DIDN'T MENTION ANYTHING ELSE IN ADDITION TO ANALGESICS FOR PAIN. WE DO NOT HAVE ANY OTHER INFORMATION CONCERNING THIS COMPLAINT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE, THE STAPLES WOULD NOT HOLD. DURING THE INITIAL INTERVENTION TO TREATMENT OF HEMORRHOIDS TYPE THREE OF THE (B)(6) 2011, THE SURGEON FOUND A BAD STAPLING ON THE ANTERIOR-LATERAL LEFT SIDE. THE DONUT WAS NOT PERFECTLY CIRCULAR. THE SURGEON PERFORMED A MANUAL SUTURE ON THE PERSISTENT ROLL NON-STAPLED. THE PATIENT COMPLAINED OF PAIN AND HAVING A HIGH FEVER (39.5 ° C) WAS REVISED ON (B)(6) 2011 AND (B)(6) 2011 FOR A CONTROL VISIT. DURING THIS LAST VISIT, THE SURGEON PERFORMED A COLONOSCOPY EXAMINATION DURING WHICH HE NOTED THAT ONE OR MORE STAPLES SEEM TO BE DISENCRUSTED OF THE TISSUE. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2011 AND IS UNDER ANALGESICS FOR PAIN. THE SURGEON BELIEVES THAT THE ORIGIN OF THESE SYMPTOMS AND THE FEVER IS NOT INFECTIOUS BUT RATHER IMMUNOALLERGIC (HISTORY OF SIMILAR REACTIONS IN PATIENT'S POST-OP). ONE DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43745

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O