BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 1839137 · Received September 20, 2010

    Report

    Report Number
    3005075853-2010-05389
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM (B)(6) OF PERITONITIS IN A MALE PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6)2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6)2010, A BAXTER CLINICAL OPERATOR WAS INFORMED ABOUT A PUNCTURED DRAIN BAG THAT WAS DETECTED BY THE PATIENT ONCE HIS THERAPY WAS COMPLETED. ON (B)(6)2010, DIANEAL THERAPY WAS DISCONTINUED. ON (B)(6)2010, 48 HOURS AFTER THE DETECTION OF THE PUNCTURED BAG, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH (UNSPECIFIED) ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). THE OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ANAL DILATOR WAS INSERTED; A PURSE STRING WAS MADE CIRCUMFERENTIALLY ON MUCOSA AND SUB-MUCOSA LAYER AND THEN TIED ON THE ANVIL. THE SURGEON SLOWLY TURNED THE KNOB IN CLOCKWISE DIRECTION AND THE ORANGE INDICATOR WAS ALMOST ON THE BOTTOM OF THE GREEN ZONE. WAITED A FEW SECONDS AND THEN FIRED THE TRIGGER; A CRUNCH SOUND WAS HEARD, THEN WAITED TWO MINUTES AND OPENED THE ANVIL. HOWEVER, THE DOCTOR FOUND A QUARTER OF RING WAS NOT FULLY CUT AND A FEW STAPLES WERE NOT WELL FORMED AND SOME DROPPED OUT; THEN HE USED A SCALPEL TO CLEAR THE RING. A SUTURE WAS NEEDED TO STOP THE BLEEDING AND CLOSE THE UN-STAPLED MUCOSA LAYERS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RP8N

    Patients

    Seq Age Sex Outcome Treatment
    1