BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAR COAGULATING SHEAR, 15MM

    MDR report key: 1760812 · Received July 19, 2010

    Report

    Report Number
    3005075853-2010-04006
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. THE BLADE TIP WAS NOT BROKE OFF AS REPORTED BY THE CUSTOMER. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP FURTHER CRACKED. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 OR A SOLID TONE ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A PROBABLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF HYPERLIPIDEMIA, ABNORMAL STRESS TEST, CONGESTIVE HEART FAILURE, CABG, SMOKING, DIABETES, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, HYPERTENSION, AND PREVIOUS CEA RECURRENT STENOSIS. THE TARGET LESION WAS THE OSTIUM OF THE RIGHT CORONARY ARTERY. PRE-PROCEDURE STENOSIS WAS 90%. LESION LENGTH WAS 15MM AND VESSEL DIAMETER WAS 6MM. THE LESION WAS MILDLY CALCIFIED. THE LESION WAS PRE-DILATED. A PRECISE PRO RX 8 X 40MM STENT WAS DEPLOYED AT THE TARGET LESION. AN ANGIOGUARD RX, SIZE 6 BASKET, WAS SUCCESSFULLY DEPLOYED AND RETREIVED DURING THE PROCEDURE. POST-PROCEDURE STENOSIS WAS 10%. THE PATIENT HAD NO NEUROLOGICAL DEFICIT WHEN HE LEFT THE ANGIOGRAPHY SUITE. THE AFTER THE PROCEDURE THE PATIENT HAD RIGHT VISUAL FIELD LOSS. THE ONSET WAS SUDDEN AND DIAGNOSIS WAS A STROKE. THE STROKE WAS DUE TO A SMALL BRANCH RETINAL ARTERY OCCLUSION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT IS WELL WITH MINIMAL VISUAL SYMPTOMS. THE PHYSICIAN INDICATED THE STROKE WAS RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP OF THE DEVICE WAS BROKEN. THE BROKEN PART DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAR COAGULATING SHEAR, 15MM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1