BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANK DILATORS 9/10 -19/20 AMERICAN SCALE

    MDR report key: 7359682 · Received March 21, 2018

    Report

    Report Number
    2916714-2018-00007
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 23, 2020
    Manufacturer
    AESCULAP INC
    Product Code
    HDQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT MD070R AND MD064R THROUGH MD069R WERE PULLED FROM STOCK. ALL LOCATIONS CONTAINED MIXED PRODUCT WITH TWO DIFFERENT DESIGNS. UPON CONTACT WITH THE MANUFACTURER MERCED, WE WERE TOLD THAT MERCED CHANGED THE PRODUCT DESIGN AND NOTIFIED AESCULAP IN EARLY 2017 ABOUT THE DESIGN CHANGE. THIS WAS COMMUNICATED TO FORMED BUYER (B)(6), BUT (B)(6) DID NOT INFORM ANYONE IN (B)(6) (INCLUDING QC/QA) ABOUT THE DESIGN CHANGE. THE NEW DESIGN HAS A SHORTER RING TO TIP MEASUREMENT THAN THE OLD DESIGN. PREVIOUS TO THIS COMPLAINT, THE LENGTH OF THE RING TO THE TIP WAS NOT LISTED AS A CRITICAL DIMENSION ON THE PRODUCT EVALUATION BUT IT SHOULD HAVE BEEN. ALL PRODUCT FROM STOCK WITH OLD DESIGN WAS SCRAPPED. MERCED PROVIDED UPDATED DRAWINGS. ONE PIECE OF EACH PART NUMBER MD064R THROUGH MD069R BEING SENT TO (B)(6) IN (B)(6) SO THAT HE CAN EVALUATE THE NEW DESIGN AND UPLOAD THE NEW DRAWINGS. ALL PRODUCT REMAINING IN STOCK IS CURRENTLY ON HOLD UNTIL THE PRODUCT IS APPROVED BY (B)(6) AND QA/QC. MD070R IS A PROCESS PACK WHICH IS MADE UP OF MD064R THROUGH MD069R, SO IT DOES NOT REQUIRE A NEW EVALUATION. ONLY THE SINGLE COMPONENTS REQUIRE THE NEW EVALUATION.

    Additional Manufacturer Narrative · 0

    A RETROSPECTIVE REVIEW OF POTENTIAL SERIOUS INJURY COMPLAINTS WAS PERFORMED. THIS MDR WAS IDENTIFIED AND FILED AS PART OF THE REVIEW ACTIVITIES. SUPPLIER: (B)(4). 12 PIECES OF MD067R AND 12 PIECES OF MD069R WERE RETURNED TO AESCULAP AND THE CUSTOMER WAS PROVIDED CREDIT FOR THAT PRODUCT. ALL PRODUCTS PRIOR TO THE DESIGN CHANGE WERE REMOVED/REPLACED. INVESTIGATION: CONDITION OF DEVICE RECEIVED: (REPORT BY (B)(4)). N/A- DID NOT RECEIVE THE COMPLAINT DEVICES BACK FOR EVALUATION. ROOT CAUSE INVESTIGATION RESULTS: LOOKING AT HISTORY OF THESE DEVICES, WE WERE ABLE TO DETERMINE THAT THE VARIANCE IN SPECIFICATIONS WAS CAUSED BY A CHANGE IN PATTERNS OVER THE YEARS. IN 2012, THE SPECIFICATIONS CHANGED . IN 2017, THE SPECIFICATIONS CHANGED WHEN WE INTRODUCED A HIGHER-GRADE PATTERN. THIS CHANGE IN PATTERN WAS APPROVED BY AESCULAP ON MARCH 2017. BASED ON THIS INFORMATION, WE CAN INFER THAT THE SETS THAT YOUR CUSTOMER HAS ARE COMPRISED OF DILATORS FROM DIFFERENT PATTERNS. CORRECTIVE ACTION TAKEN: N/A- WE WILL CONTINUE TO TREND FOR THIS ISSUE TO PREVENT FURTHER REOCCURRENCE. FURTHERMORE, WE WILL ENSURE THAT BOTH AESCULAP AND (B)(4) ARE IN ALIGNMENT WHEN A NEW PATTERN IS INTRODUCED. DEVICE DISPOSITION: PER AESCULAP, ANY DILATORS IN INVENTORY THAT WERE COMPRISED OF THE PATTERN SUPPLIED BY (B)(4) BEFORE 2017 WERE SCRAPPED TO PREVENT FUTURE SETS BEING SOLD WITH MIXED PATTERNS OF VARYING SIZES. (B)(4) PROVIDED INSPECTION DRAWINGS FOR THE DEVICES TO AESCULAP ON 3/15/18. IN THE INTERIM, WE HELD ALL INVENTORY FOR CONTAINMENT. ON 3/22/18, (B)(4) RECEIVED APPROVAL FROM AESCULAP TO RELEASE ANY OPEN ORDERS.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: USA INSERTION OF PRODUCT IN TO ANATOMY AND ALMOST CAUSED PERFORATION BECAUSE THE RINGS DO NOT LINE UP CORRECTLY, NO HARM TO THE PATIENT REPORTED. 15 MINUTED DELAY IN SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199875 HANK DILATORS 9/10 -19/20 AMERICAN SCALE GENERAL SURGICAL INSTRUMENTS HDQ AESCULAP INC MD070R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other