BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE ESOPHAGEAL BALLOON

    MDR report key: 1882690 · Received October 20, 2010

    Report

    Report Number
    1037905-2010-00536
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT IS SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. DAMAGE TO THE BALLOON CATHETER COULD HAVE OCCURRED IF THE BALLOON DILATOR REC'D EXCESSIVE PRESSURE DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE AND/OR GENERAL HANDLING. A POSSIBLE CONTRIBUTING FACTOR IS INADEQUATE LUBRICATION OF THE BALLOON WITH A WATER SOLUBLE LUBRICANT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE RPTR COULD NOT SPECIFY IF THE BALLOON WAS LUBRICATED PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY TO MAINTAIN BALLOON DEFLATION. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE RPTR COULD NOT SPECIFY IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON DEVICE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. DIFFICULTY WITH BALLOON DEFLATION AND REMOVAL FROM THE ENDOSCOPE CAN OCCUR IF THE BALLOON CATHETER IS COMPROMISED. FOR EXAMPLE, IF THE BALLOON DILATOR CATHETER HAS A VOID SUCH AS A SPLIT, FULL BALLOON DEFLATION MAY BE PROHIBITED. INCOMPLETE BALLOON DEFLATION COULD CREATE DIFFICULTY IN REMOVING THE BALLOON FROM THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: "A COMPROMISED BALLOON MAY PROHIBIT REMOVAL FROM THE ENDOSCOPE ACCESSORY CHANNEL. REMOVAL OF THE ENDOSCOPE ALONG WITH THE COMPROMISED BALLOON MAY BE REQUIRED." PRIOR TO DISTRIBUTION, THIS PRODUCT IS SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC DILATION PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY HERCULES BALLOON DILATOR. WHEN ATTEMPTING TO REMOVE THE BALLOON FROM THE ENDOSCOPE ACCESSORY CHANNEL, THE BALLOON WOULD NOT DEFLATE. THE CATHETER OF THE BALLOON DEVICE WAS REPORTEDLY "STRIPPING" (I.E. CRACK OR SPLIT IN CATHETER MATERIAL PROHIBITING FULL DEFLATION). IT IS BELIEVED THEY WERE ABLE TO COMPLETE THE DILATION PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE ESOPHAGEAL BALLOON KNQ, ESOPHAGEAL DILATOR KNQ COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION DEVICE| OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)