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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION TRIPLE LUMEN NEEDLE KNIFE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY FUSION TRIPLE LUMEN NEEDLE KNIFE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number FS-PRECUT
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
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. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. 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. Needle knife breakage near the distal end can occur if the product experiences limited movement of the needle knife during electrocautery application. The instructions for use state: "caution: it is essential to move cutting wire while applying current. Maintaining cutting wire in one position may cause excessive focal coagulation, charring of tissue and/or damage to cutting wire. " maintaining the needle knife in one position can result in breakage of the needle knife. This is the most likely cause of needle breakage. Needle knife breakage near the distal end can also occur if the device is used with excessive cautery settings or if the needle makes contact with the distal end of the endoscope during a cautery application. The instructions for use direct the user: "before using this papillotome, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode. Ensure a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure. When applying current, contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to endoscope. " prior to distribution, all fusion triple lumen needle knives are subjected to a visual inspection and functional test to ensure device integrity. A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. 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.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion triple lumen needle knife. In an attempt to cannulate the common bile duct (cbd) without success, the needle knife broke off inside the patient and was unable to retrieve it. The tip of the needle knife remained inside the patient¿s body. An attempt was made to remove the device portion from the patient, but failed. According to the initial reporter, the patient had a prolonged hospital stay.
 
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Brand NameFUSION TRIPLE LUMEN NEEDLE KNIFE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key11133663
MDR Text Key225733730
Report Number1037905-2021-00009
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-PRECUT
Device Lot NumberW4344817
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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