BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI VISITEC

    MDR report key: 2541749 · Received April 11, 2012

    Report

    Report Number
    1211998-2012-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 10, 2012
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 20,000 UNITS MANUFACTURED IN LOT 3000434 ON (B)(6), 2011. ALL TESTS AND INSPECTIONS WERE ACCEPTABLE. NO ANOMALIES WERE NOTED IN THE DHR THAT POINT TO A POTENTIAL FOR TIP DAMAGE. THE RAW PARTS ARE RECEIVED WITH PROTECTIVE SHEATHS AND AUTOMATICALLY REMOVED BY THE CYSTOTOME MACHINE PRIOR TO FORMING. TO PREVENT TIP DAMAGE AFTER FORMING, THE CYSTOTOME IS ORIENTATED BY A VISION SYSTEM PRIOR TO THE AUTOMATIC SHEATHING. THE PRODUCTION CONTROL PLAN REQUIRES INSPECTION FOR DIMENSIONAL AND VISUAL DAMAGE AT SETUP AND 6 SAMPLES EVERY HOUR DURING PRODUCTION TO ASSURE THE PRODUCT CONTINUES TO CONFORM TO SPECIFICATION. A REVIEW OF THE COMPLAINT DATABASE FROM (B)(6) 2011 TO (B)(6) 2012 DID NOT FIND ANY OTHER OCCURRENCE FOR TIP DAMAGE ON REF (B)(4) CYSTOTOMES. ABOUT 10 INVENTORY SAMPLES WERE PULLED FROM EACH LOT OF 3007469 AND 3019188. ALL SAMPLES WERE INSPECTED UNDER 20-100X MAGNIFICATION. NO TIP DAMAGE WAS OBSERVED ON ANY INVENTORY SAMPLE INSPECTED. THE CYSTOTOME TIP IS VERY DELICATE AND CAN BE DAMAGED IF IT IS IMPROPERLY HANDLED DURING PACKAGE REMOVAL OR ACCIDENTALLY COMES INTO CONTACT WITH ANOTHER HARD SURFACE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME SINCE THIS APPEARS TO ISOLATED. HOWEVER WE WILL CONTINUE TO TRACK FOR THIS DEFECT AND TAKE ADDITIONAL ACTION IF NECESSARY. WE TAKE THIS REPORT SERIOUSLY AND PLAN TO DISCUSS IT WITH PRODUCTION OPERATORS SO THEY UNDERSTAND THE IMPACT THEY HAVE ON SAFETY, QUALITY AND CUSTOMER SATISFACTION.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER REPORTED VERBATIM, ¿CYSTOTOME TIP ON AFFECTED LOT HAS AN EXTRA CURVE AT END. THIS HAS CAUSED THE CAPSULE TO TEAR INCORRECTLY IN 4 CASES. THIS CAN BE OBSERVED UNDER MICROSCOPE IMMEDIATELY AFTER THE CYSTOTOMES ARE REMOVED FROM PACKAGING.¿ (B)(6) WAS CONTACTED ON (B)(6) 2011 AT 11:30 EDT. SHE EXPLAINED THAT THE SURGEON PERFORMS 5 MINUTE SURGERIES AND THAT THIS WAS AN INCONVENIENCE TO HIM. NO PATIENT INJURY IN ANY OF THE FOUR CASES. IT JUST SLOWED HIM DOWN. SHE DOES NOT THINK THAT HE LOOKED AT THEM PRIOR TO USING THEM, BUT SHE IS NOT ABSOLUTELY SURE. THE 4 RETURNED COMPLAINT SAMPLES WERE EVALUATED. TWO OF THE SAMPLES WERE RECEIVED IN OPEN PACKAGES WITHOUT THE PROTECTIVE SHEATHES AND 2 WERE RECEIVED IN UNUSED AND SEALED PRIMARY PACKAGES. THE 2 OPENED AND UNPROTECTED CYSTOTOMES HAD DAMAGED TIPS. THE 2 SEALED PRIMARY PACKAGES DID NOT HAVE ANY TIP DAMAGE AND WERE ACCEPTABLE. NO PRODUCT FROM LOT 3000434 REMAINED IN INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BVI VISITEC IRRITATING CYSTOTOME .50 X 16MM HMX BEAVER-VISITEC INTERNATIONAL NA 3000434

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK