BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1852531 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05675
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE BLADE DISCOLORED (BLUE) DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. THE BLADE WAS FOUND TO BE BROKEN AT THE DISCOLORED (BLUE). PROBABLE CAUSE OF BLADE DISCOLORATION IS APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING REFILLING THE HEATER IN LAST FILL. THE FILL VOLUME (FV) EQUALED 658ML. THE HOME PATIENT (HP) HAD DISCONNECTED AND USED THE WRONG SIZED BAGS THE NIGHT BEFORE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HP END THERAPY AS THE HP HAD DISCONNECTED. THE HP HAD CONTACTED THE REGISTERED NURSE (RN) AND WOULD FINISH WITH MANUAL SUPPLIES. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2010 REGARDING DISCONNECTING DUE TO USING WRONG SIZED BAGS. THE HP DENIED DISCONNECTING OR USING WRONG SIZED BAGS. THE HP WAS OFFENDED AT SUGGESTING THAT HE HAD USED WRONG BAGS AND STATED THAT HE DID NOT DO ANYTHING WRONG. THE HP STATED THAT HE IS FINE AND CONFIRMED THAT HE IS CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN RESECTION PROCEDURE, THE BLADE WAS BROKEN OFF INSIDE THE PATIENT. AS THE BROKEN PIECE WAS RETRIEVED, NO PIECES WERE LEFT INSIDE THE PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT THE BLADE HAD NOT TOUCHED A FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G4T76X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE