BEUDAMED
    FDA Adverse Event Other Summary report: N

    SANI-SCOPE DISP ANOSCOPE

    MDR report key: 4955924 · Received July 29, 2015

    Report

    Report Number
    1216677-2015-00043
    Event Type
    Other
    Date Received
    July 29, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 20, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FER
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW FOR THE 2 YEAR COMPLAINT HISTORY FOR THE SANI-SCOPE DISP ANOSCOPE SHOWED (B)(4) SIMILAR COMPLAINT. THE SANI-SCOPE DISP ANOSCOPE HAS NOT HAD ANY RELATED PRODUCT DESIGN OR PRODUCT SPECIFICATION CHANGES IN THE LAST 2 YEARS. THE SANI-SCOPE DISP ANOSCOPE IS A PURCHASED PRODUCT AND IT IS NOT LOT CONTROLLED. A 2 YEAR REVIEW OF INCOMING INSPECTION RECORDS SHOWS THE SANI-SCOPE DISP ANOSCOPE WERE TO SPECIFICATION UPON RECEIPT. THE LAST SHIPMENT OF SANI-SCOPE DISP ANOSCOPE TO (B)(4) PRIOR TO THIS COMPLAINT WAS 6/22/2015. A REVIEW OF FG INVENTORY WAS DONE AT C=0 AQL 1.0 ((B)(4) PIECES). THE REVIEW AND INSPECTION SHOWED THE ((B)(4)) SANI-SCOPE DISP ANOSCOPE WERE TO SPECIFICATION. THERE WAS NO SEPARATION OF THE ROUND TIP. THE REPORTED CONDITION COULD NOT BE CONFIRMED AS THE ACTUAL SAMPLE WAS NOT RETURNED. THE COMPLAINT WILL BE RE-OPENED AND RE-EVALUATED IF ADDITIONAL INFORMATION OR THE SAMPLE BECOMES AVAILABLE. AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED AS THE PRODUCT MET ALL APPROVED RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE BEFORE THEY WERE RELEASED. LIKELY CAUSE OF THE REPORTED COMPLAINT CONDITION IS CONCEALED DAMAGE DUE TO MISHANDLING DURING SHIPPING AND OR EXCESSIVE PULL FORCE EXCEEDING THE 15LB SPECIFICATION. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. NO CORRECTIVE ACTION NEEDED BY COOPERSURGICAL AT THIS TIME. THIS COMPLAINT WILL BE ENTERED INTO COOPERSURGICAL'S CONTINUOUS IMPROVEMENT PROGRAM (CIP). ALL COMPLAINTS IN THE CIP PROGRAM ARE TRENDED AND REVIEWED ON A QUARTERLY BASIS BY MANAGEMENT AT COOPERSURGICAL TO DETERMINE APPROPRIATE COURSE OF ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANOSCOPE - PART NUMBER 82420 - BROKE OFF INSIDE THE PATIENT AND HAD TO BE RETRIEVED. REFERENCE E-COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493660 SANI-SCOPE DISP ANOSCOPE SANI-SCOPE DISP ANOSCOPE FER COOPERSURGICAL, INC. 82420 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1