MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC COOK SNAPLOC WIRE GUIDE LOCKING DEVICE; ENDOSCOPE CHANNEL ACCESSORY

Model Number	G59685
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued e1 - phone number: (b)(6).The investigation remainss on-going.A follow-up emdr will be provided within 30 days of receipt of new information.
Additional Manufacturer Narrative
Continued e1 - phone number :(b)(6).The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook snaploc wire guide locking device.It was reported that when the accessory extraction balloon entered the device, it is assumed that the silicone seal of the wire lock unknowingly went into the channel of the scope with the balloon and was subsequently lost inside the patient.Doctor only realized the seal was missing when he noticed a lot of air was leaking from the scope.By that time the seal could not be traced, so it was assumed that it was inside the patient.The silicone seal section of the snaploc was not retrieved.Per initial reporter it is assumed that the silicone sealing device unknowingly went into the channel of the scope with the balloon and was subsequently lost inside the patient and was not retrieved.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued e1 - phone number: (b)(6).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.Our evaluation of the product said to be involved confirmed the report.The silicone disc/ seal has dislodged from the wire lock housing and was not included in the return.No damage to the wire lock housing was observed.A lab meeting was held with r&d on 03nov2025.No anomalies were observed with the wire lock housing as returned.The device was returned to the supplier for evaluation, and they provided the following information: "the returned sample does not exhibit any evidence of improper assembly.Based on current observations, it is projected that the seal may have disengaged from the component due to the application of external force -particularly if the device was pulled in the reverse direction, potentially compromising the integrity of the seal.[device exchange] missing (fuji} - dimensions measured from return sample min of.470 (2x), actual.477 &.479, dim.529 -.539 (2x), actual.535 &.534.Please note that the internal seal is positioned within a keyed pocket in the bottom component.This seal is retained by the assembly of three components: the bottom housing and two upper parts, which are permanently joined through a welding process only." a product discrepancy or anomaly that could have contributed to this reported occurrence was not observed, the root cause was not identified.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.Additionally, the seal was not provided in the return, prohibiting a complete evaluation.This limits our ability to conclusively determine a cause.However, a dimensional analysis of the returned portion confirmed the device was conforming.In addition, it was concluded it is not likely the seal was able to enter the endoscope or the patient as the size of the seal would not fit within the endoscope channel.Prior to distribution, all snaploc wire guide locking devices are subjected to a visual inspection 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 remote.Quality assurance will continue to monitor for complaint trends.

• Brand Name: COOK SNAPLOC WIRE GUIDE LOCKING DEVICE
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• 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; winston-salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 23436531
• Report Number: 1037905-2025-00738
• Device Sequence Number: 8672155
• Product Code: ODC
• UDI-Device Identifier: 00827002596856
• UDI-Public: (01)00827002596856(17)280414(10)W4930377
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K213483
• 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,Followup,Followup
• Report Date (Section B): 12/18/2025

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: G59685
• Device Catalogue Number: SNAPLOC-F
• Device Lot Number: W4930377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/24/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: BOSTON SCIENTIFIC AUTOTOME WITH JAGWIRE; BOSTON SCIENTIFIC EXTRACTOR PRO BALLOON; FUJINON DUODENOSCOPE
• Patient Sex: Unknown