MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION TRIPLE LUMEN NEEDLE KNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WIHTOUT ACCESSORIES)

Model Number	G31539
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure, the physician used a cook fusion triple lumen needle knife.It was reported that during use, the blade remained implanted in the patient, detaching from the device.The customer opened the package and tested the device, all was good.Once in good position, in front of the papilla without too much bending, they inserted the device into the scope channel and the physician asked to deploy the needle, they started to cut the papilla, but the needle broke and stayed in the papilla.They removed the needle, took another system and they finished examination without problem.It was reported that no section of the device remained inside the patient's body, a piece of the needle detached, but no further information was provided on how it was retrieved.The initial reporter also stated that the patient did not require any additional procedures, and did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.The photo provided shows a segment of the needle knife which remains imbedded in the tissue.Our laboratory evaluation of the product said to be involved confirmed the report.The product was returned with the handle lock loosened and with the handle retracted.A large amount of a red substance was noted within the distal catheter.The handle was advanced fully and a portion of the needle knife, measuring 3.5mm, remains attached.The needle knife has beaded at the fracture point and shows evidence of a cautery application (blackening of the needle knife).The detached portion of the needle knife was also included in the return, taped to the pouch.The detached portion measures 6.0mm.The distal end of the needle knife segment tip remains smooth and rounded and shows evidence of a cautery application (blackening of the needle knife).The proximal end of the broken fragment is also blacked and has beaded at the fracture point, corresponding to the distal end of the segment which had remained attached to the device.No portion of the needle knife appears to be missing.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: our laboratory evaluation of the returned device confirmed the needle detached from the device.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 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 device, 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." the instructions for use caution the user: "when applying current, ensure the cutting wire is completely out of the endoscope.Contact of the cutting wire with the endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the 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 the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: FUSION TRIPLE LUMEN NEEDLE KNIFE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WIHTOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27407
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105
• MDR Report Key: 22440276
• Report Number: 1037905-2025-00504
• Device Sequence Number: 4670136
• Product Code: KNS
• UDI-Device Identifier: 00827002315396
• UDI-Public: (01)00827002315396(17)280206(10)W4912004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G31539
• Device Catalogue Number: FS-PRECUT
• Device Lot Number: W4912004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, UNKNOWN MAKE OR MODEL
• Patient Sex: Unknown