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U.S. Department of Health and Human Services

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

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WILSON-COOK MEDICAL INC 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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used two (2) cook fusion triple lumen needle knives. It was reported that while using the first device, its tip broke off. Another device with the same lot was used to continue the procedure. The tip of this one also broke off during use. The incision made was large enough to continue the procedure without a third device. The broken tip has been removed from the patient using biopsy forceps. Photos provided depict an endoscopic view of the detached portions. A section of the device did not remain inside the patient¿s body. The broken tip has been removed from the patient using biopsy forceps. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation evaluation: the two products said to be involved was returned in a bio bag. Provided with the return were two open pouches from the lot number provided in the report. The label matches the product returned. The photo provided by the customer depict an endoscopic view of the detached portions. The length of each section is unknown. Device 1: our laboratory evaluation of the returned device said to be involved confirmed the report. A portion of the needle measuring approximately 3. 0mm was missing and not included with the return of the device. The needle remaining shows evidence of cautery application. The catheter shows no kinks/bends. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. Device 2: our laboratory evaluation of the returned device said to be involved confirmed the report. A portion of the needle measuring approximately 2. 0mm was missing and not included with the return of the device. The needle remaining shows evidence of cautery application. The catheter shows no kinks/bends. A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed. 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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. 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.
 
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Brand NameFUSION TRIPLE LUMEN NEEDLE KNIFE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key13956427
MDR Text Key290443114
Report Number1037905-2022-00149
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K040981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-PRECUT
Device Lot NumberW4546633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2021
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: 03/30/2022 Patient Sequence Number: 1
Treatment
ENDOSCOPE, UNKNOWN MAKE AND MODEL
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