BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 8020209 · Received October 30, 2018

    Report

    Report Number
    1820334-2018-03131
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 27, 2018
    Manufacturer
    COOK INC
    Product Code
    KOE
    PMA / PMN Number
    K961904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICES WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. TWO USED PARALLEL FLEXOR SHEATHS WITH DILATORS WERE RETURNED FOR INVESTIGATION. THE DILATORS AND SHEATHS WERE RETURNED UNASSEMBLED. UNDER MAGNIFICATION, THE INSIDE OF BOTH SHEATHS SHOWED SIGNS OF DAMAGE ON THE SIDE WALL. A STRING OF CLEAR LINING FROM INSIDE OF ONE SHEATH WAS REMOVED. NO MANUFACTURING ANOMALIES WERE VISIBLE ON THE DILATORS OR SHEATHS. BOTH SHEATHS WERE CONFIRMED TO BE DAMAGED BY A SHARP OBJECT DURING USE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 8160958 AND 8769254 FOUND THERE WERE NO NON-CONFORMANCES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. A SEARCH OF COMPLAINT RECORDS FOR LOT 8160958 AND LOT 8769254 REVEALED THIS IS THE ONLY COMPLAINT RECEIVED FOR THESE COMPLAINT DEVICE LOT NUMBERS. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANIES THIS DEVICE PROVIDES THE FOLLOWING: PRECAUTIONS NEVER USE UNDUE FORCE FOR PLACEMENT OF THIS DEVICE. NEVER USE UNDUE FORCE WHILE RELEASING THE WIRE IN THE RAPID RELEASE TECHNIQUE. INSTRUCTIONS FOR USE NOTE: PRIOR TO PLACEMENT, ACTIVATE THE HYDROPHILIC COATING BY REMOVING THE DILATOR FROM THE FLEXOR SHEATH AND IMMERSING ALL COMPONENTS IN STERILE WATER OR ISOTONIC SALINE. THIS WILL ALLOW THE HYDROPHILIC SURFACE TO ABSORB WATER AND BECOME LUBRICIOUS, EASING PLACEMENT UNDER STANDARD CONDITIONS. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. BOTH OF THE DEVICES DISPLAYED EVIDENCE OF SCRATCH MARKS ON THE INNER SHEATH. THE COATING HAD BEEN PUSHED OUT OF ONE OF THE DEVICES, IN WHICH A PIECE OF CLEAR LINING WAS RETAINED FROM THE INNER LINER OF THE SHEATH. BOTH RETURNED DEVICES WERE CONFIRMED TO BE DAMAGED BY A SHARP OBJECT DURING USE. THE CAUSE HAS BEEN TRACED TO THE USER; UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, IN A FLEXOR PARALLEL A LITTLE PIECE OF COATING DETACHED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. DURING A RETROGRADE INTRARENAL SURGERY (RIRS) RIGHT KIDNEY, THE STONE WAS VERY HARD AND DURING THE PROCEDURE WITH EXTRACTOR AND STONE INSIDE, THE STONE SCRATCHED THE FLEXOR PARALLEL URETERAL ACCESS SHEATH COATING AND A LITTLE SLICE WENT INTO THE KIDNEY. THE DOCTOR WAS ABLE TO REMOVE THIS LITTLE PIECE OF COATING WITH THE EXTRACTOR. NO ADDITIONAL PROCEDURE WAS REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859165 FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS KOE DILATOR, URETHRAL KOE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HWS-035150, HLF-S273-H30, NGE-017115.