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

Model Number	G24885
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure, the physician used a cook huibregtse triple lumen needle knife.It was reported that during the papillotomy, the needle fell off.According to the initial reporter, a section of the device remained inside the patient¿s body.The needle tip couldn't be retrieved as the object moved due to peristalsis directly into jejunum.No further information was provided by the initial reporter, and it was stated that the patient did not require any additional procedures and the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued: e1 phone number: (b)(6).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.Prior to distribution, all huibregtse 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.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE
• Common Device Name: 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): WILSON-COOK MEDICAL INC; 4900 bethania station rd; NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 21634338
• Report Number: 1037905-2025-00214
• Device Sequence Number: 7535568
• Product Code: KNS
• UDI-Device Identifier: 00827002248854
• UDI-Public: (01)00827002248854(17)270521(10)W4839209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G24885
• Device Catalogue Number: HPC-3
• Device Lot Number: W4839209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 05/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown