BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLE CEV10195R DIA 5MM ANG W/ RATCHET [MXI/XOM]

    MDR report key: 2947696 · Received February 7, 2013

    Report

    Report Number
    1045254-2013-00073
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). HANDLE CEV10195R DIA 5MM ANG W/ RATCHET, LOT: 12/05 (1), LOT: 11/05 (1), LOT: 04/03 (2). INSERT CEV625-1 FENESTRATED 350MM, LOT: 02/08 (1), LOT: 101101 (1), LOT: 04/03 (2). TUBE CEV649-5B DIA 5MM 350MM, LOT: 081212 (1), LOT: 100604 (1), LOT: UNKNOWN (2). DEVICE EVALUATION: 12 DEVICES WERE RETURNED FOR THIS COMPLAINT EVENT. THE ACCOUNT COULD NOT SPECIFY WHICH DEVICE CAUSED THE PERFORATION. EVALUATION OF THE 4 RETURNED HANDLE (CEV10195R): THREE OF THE FOUR HANDLES RETURNED PRESENT SOME LASER ETCHING NOT APPLIED BY (B)(4) (MEDTRONIC): "ALIA 1209D"; "ALIA 1204"; DM1112". THIS INDICATES THAT THE INSTRUMENTS WERE PROBABLY REPAIRED/ MODIFIED BY A THIRD PARTY NOT QUALIFIED BY MEDTRONIC. THE MONOPOLAR CONNECTION PIN WAS DAMAGED ON THE HANDLE INSCRIBED WITH "DM1112". NO SIGNIFICANT FUNCTIONING DEFECT WAS HIGHLIGHTED. FURTHERMORE, THESE INSTRUMENTS HAVE NEVER BEEN SERVICED NOR REPAIRED BY (B)(4) (MEDTRONIC). EVALUATION OF THE 4 RETURNED INSERT (CEV625-1): THE INSTRUMENTS WERE SIGNIFICANTLY BENT. THREE OF THE INSERTS HAD A PIN THAT WAS DIFFERENT FROM SPECIFICATION. THERE WERE NOTICEABLE TRACES OF IMPACT FOUND ON THE JAWS. THE OBSERVED DAMAGE TO THE JAWS COULD DIMINISH THE JAW'S NON-TRAUMATIC PROPERTIES AND AS A RESULT POSSIBLY RESULT IN DAMAGE TO TISSUE. DEVICE EVALUATION DETERMINED THAT THE INSTRUMENTS HAD PROBABLY BEEN REPAIRED/ MODIFIED BY A THIRD PARTY NOT QUALIFIED BY MEDTRONIC. EVALUATION OF THE 4 TUBE (CEV649-5B): THREE OF THE TUBES HAD SHEATHING FROM A MATERIAL DIFFERENT FROM OUR SPECIFICATIONS. THE TUBE FROM BATCH 081212 WAS SIGNIFICANTLY BENT AND HAD A DAMAGED SHEATH. THE DAMAGES HIGHLIGHTED ON THE SHEATHING AND THE COATING COULD HAVE DEGRADED THE INSULATING PROPERTIES OF THE TUBES AND LED TO POTENTIALLY UNCONTROLLED COAGULATIONS. THE PRESENCE OF NON-MEDTRONIC SHEATHS INDICATES THAT THE INSTRUMENTS HAD PROBABLY BEEN REPAIRED/ MODIFIED BY A THIRD PARTY NOT QUALIFIED BY MEDTRONIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USE OF A COELIOSCOPY INSTRUMENT FOR DISSECTION LED TO THE PERFORATION OF THE SMALL INTESTINE. IT WAS REPORTED THAT THE JAWS DID NOT HAVE THE EXPECTED ATRAUMATIC PROPERTIES AND WERE CUTTING THE TISSUES. THE PERFORATION WAS DETECTED AND SOLVED DURING THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52981 HANDLE CEV10195R DIA 5MM ANG W/ RATCHET [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC, INC. CEV10195R 12/05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention