BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEBRA SEALER 2380 AND SEBRA SEALER HEAD 1105

    MDR report key: 2030904 · Received March 21, 2011

    Report

    Report Number
    1219343-2011-00003
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 14, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: DEVICE MANUFACTURE DATE: (B)(4) 1994. THE EQUIPMENT WAS RETURNED TO HAEMONETICS FOR EVAL ON (B)(4) 2011. THE SEALER POWER SUPPLY, (B)(4) WAS EVALUATED. THE SEALER POWER SUPPLY OPERATED CORRECTLY AND NO DEFECT WAS FOUND. THE HAND HELD SEALING HEAD, (B)(4) WAS FOUND TO BE OUT OF SPECIFICATION FOR RESISTANCE AND PHASE ANGLE. THE JAWS WERE FOUND TO BE DIRTY AND THE EQUIPMENT REQUIRED MAINTENANCE. THE EQUIPMENT DID NOT OPERATE CORRECTLY, AS AN ELECTRICAL ARC WAS GENERATED DURING OPERATION. THE JAWS, JAW HOLDER, AND MAGNETIC SWITCH WERE REPLACED. THE SEALING HEAD WAS DAMAGED DUE TO ARCING, CAUSED BY CONTAMINATION OF THE SEALING REGION. AFTER SERVICE, THE EQUIPMENT OPERATED CORRECTLY. CLEANING INSTRUCTIONS ARE COVERED IN THE MANUAL AS WELL AS TROUBLESHOOTING INSTRUCTIONS FOR DAMAGED JAW. ALSO, THE MANUAL CONTAINS A WARNING ASSOCIATED WITH ARCING, WHICH MAY LEAD TO BURNS IF THE EQUIPMENT IS NOT CLEANED AND/OR MAINTENANCE PERFORMED IN ACCORDANCE WITH (B)(4), MANUAL REVISION (B)(4). THIS INCIDENT IS DUE TO FAILURE TO MAINTAIN THE EQUIPMENT.

    Description of Event or Problem · 1

    THE NURSE, WHILE SEALING A TUBE FILLED WITH SALINE SOLUTION, EXPERIENCED PAIN WHILE OBSERVING SPARKS BETWEEN HER FOREFINGER AND THE SEALING APPARATUS. A MEDICAL CERTIFICATE FROM (B)(6) 2011 CONFIRMS A BURN WITH PAIN DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEBRA SEALER 2380 AND SEBRA SEALER HEAD 1105 TUBING SEALER AND SEALER HEAD GKT HAEMONETICS CORP. 2380/1105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA