BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 8907275 · Received August 19, 2019

    Report

    Report Number
    1037905-2019-00476
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    June 4, 2018
    Report Date
    July 23, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K990130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    JAGIELSKI, M., SMOCZYNSKI, M., & ADRYCH, K. (2018). THE ROLE OF ENDOSCOPIC TREATMENT OF PANCREATIC DUCT DISRUPTION IN PATIENTS WITH WALLED-OFF PANCREATIC NECROSIS. SURGICAL ENDOSCOPY, 32(12), 4939-4952. DOI:10.1007/S00464-018-6255-4 CONTINUED FROM SECTION B3: 2001 TO 2016. CONTINUED FROM SECTION D11: OLYMPUS FLOW-CUT KD-301Q0725 SPHINCTEROTOME, BOUGIETYPE 7, 8.5 OR 10 FR DILATOR (WILSON-COOK), NASAL DRAIN (7 FR OR 8 FR BALTON OR WILSON-COOK) DATE RANGE OF THE INFORMATION CONTAINED IN THE ARTICLE: 2001- 2016 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE ZIMMON STENT PRODUCT LINE WAS TRANSFERRED TO COOK IRELAND LTD IN 2009 AND 2010. COMPLAINTS AND DISTRIBUTION OF ZIMMON STENTS ARE NOW MONITORED BY COOK IRELAND. ZIMMON STENTS HAVE A THREE YEAR EXPIRATION DATE, THEREFORE ALL ZIMMON STENTS MANUFACTURED AND DISTRIBUTED BY COOK ENDOSCOPY ARE BEYOND THEIR EXPECTED LIFE. THE ZIMMON STENTS WERE THEREFORE EXCLUDED FROM THE RISK ASSESSMENT AND COMPLAINT REVIEW. PRIOR TO DISTRIBUTION, ALL GEENEN AND ZIMMON PANCREATIC STENTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY FOR GEENEN PANCREATIC STENTS WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING TWO (2) ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) PROCEDURES, THE PHYSICIAN USED TWO (2) COOK GEENEN AND/OR COOK ZIMMON PANCREATIC STENT, AS DESCRIBED IN THE BELOW EXCERPTS OF AN ARTICLE. "...IN PATIENTS WHO UNDERWENT ACTIVE TRANSPAPILLARY DRAINAGE, SPHINCTEROTOMY WAS PERFORMED DURING ERP, FOLLOWED BY MECHANICAL DILATATION OF THE MAIN PANCREATIC DUCT USING A BOUGIETYPE 7, 8.5 OR 10 FR DILATOR, NASAL DRAIN, AND PANCREATIC ENDOPROSTHESIS (5¿10 FR GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR OTHER MANUFACTURER'S DEVICE) WERE INTRODUCED THROUGH THE PAPILLA... ...COMPLICATIONS OF ERP WERE REPORTED...TWO (2) [PATIENTS] HAD INTRADUCTAL PANCREATIC STENT FRAGMENTATION." IT WAS NOT PUBLISHED IN THE ARTICLE IF THE FRAGMENTED PORTION(S) WERE RETRIEVED. HOWEVER, IT IS LIKELY THAT THE FRAGMENTED PORTIONS HAD TO BE RETRIEVED. IT IS UNKNOWN IF THE PATIENTS EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT NO ADVERSE EFFECTS WERE REPORTED IN THE PUBLISHED CASE REPORT.

    Additional Manufacturer Narrative · 1

    JAGIELSKI, M., SMOCZYNSKI, M., & ADRYCH, K. (2018). THE ROLE OF ENDOSCOPIC TREATMENT OF PANCREATIC DUCT DISRUPTION IN PATIENTS WITH WALLED-OFF PANCREATIC NECROSIS. SURGICAL ENDOSCOPY, 32(12), 4939-4952. DOI:10.1007/S00464-018-6255-4. DATE OF EVENT: 2001 TO 2016. CONCOMITANT MEDICAL PRODUCTS: OLYMPUS FLOW-CUT KD-301Q0725 SPHINCTEROTOME, BOUGIETYPE 7, 8.5 OR 10 FR DILATOR (WILSON-COOK), NASAL DRAIN (7 FR OR 8 FR BALTON OR WILSON-COOK). DATE RANGE OF THE INFORMATION CONTAINED IN THE ARTICLE: 2001- 2016. INVESTIGATION EVALUATION; THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH FURTHER INFORMATION.

    Description of Event or Problem · 1

    DURING TWO (2) ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) PROCEDURES, THE PHYSICIAN USED TWO (2) COOK GEENEN AND/OR COOK ZIMMON PANCREATIC STENT, AS DESCRIBED IN THE BELOW EXCERPTS OF AN ARTICLE. "IN PATIENTS WHO UNDERWENT ACTIVE TRANSPAPILLARY DRAINAGE, SPHINCTEROTOMY WAS PERFORMED DURING ERP, FOLLOWED BY MECHANICAL DILATATION OF THE MAIN PANCREATIC DUCT USING A BOUGIETYPE 7, 8.5 OR 10 FR DILATOR, NASAL DRAIN, AND PANCREATIC ENDOPROSTHESIS (5¿10 FR GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR OTHER MANUFACTURER'S DEVICE) WERE INTRODUCED THROUGH THE PAPILLA. COMPLICATIONS OF ERP WERE REPORTED. TWO (2) [PATIENTS] HAD INTRADUCTAL PANCREATIC STENT FRAGMENTATION." IT WAS NOT PUBLISHED IN THE ARTICLE IF THE FRAGMENTED PORTION(S) WERE RETRIEVED. HOWEVER, IT IS LIKELY THAT THE FRAGMENTED PORTIONS HAD TO BE RETRIEVED. IT IS UNKNOWN IF THE PATIENTS EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT NO ADVERSE EFFECTS WERE REPORTED IN THE PUBLISHED CASE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701342 UNKNOWN FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PENTAX ED3490TK AND PENTAX EG3870UTK ECHOENDOSOPE