MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

Model Number	G22700
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: section g: pma/510(k): k173673.Investigation evaluation: a product evaluation was performed only by the diagram provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the diagram provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and the diagram describing the event.The diagram provided shows the snare catheter and handle and an arrow is point to the base of the handle, indicating the sheath is buckled, thus confirming the complaint of 'torsion' by the user.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 evaluation of the diagram confirmed the report, however, 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 acusnare polypectomy snares are subjected to a visual inspection and functional testing 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.
Event or Problem Description
During a colonoscopy examination, the physician used a two cook acusnare polypectomy snares.It was reported [that] perforation was observed during polyp removal.Customer provided a snare diagram and indicated that torsion was experienced at the base of snare at the time of use.A section of the device did not remain inside the patient¿s body.The patient required an unknown additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the products said to be involved were returned in a clear plastic bag with two open pouches from the lot number provided in the report.The labels match the products returned.The diagram provided by the user shows the snare catheter and handle and an arrow is point to the base of the handle, indicating the sheath is buckled, thus confirming the complaint of 'torsion' by the user.Devices #1 - #2: our laboratory evaluation of the products said to be involved confirmed the report.The devices were returned with the snare heads fully retracted into the sheaths.A visual inspection identified kinking from the proximal end of the handle to 0.7cm for the first device and from the proximal end of the handle to 0.9cm for the second device.The devices were function tested and the snares advanced/retracted when the handle was manipulated with some resistance.No other anomalies were detected with the devices.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 evaluation of the returned devices confirmed the report.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.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection and functional testing 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.
Event or Problem Description
During a colonoscopy examination, the physician used a two cook acusnare polypectomy snares.It was reported [that] perforation was observed during polyp removal.Customer provided a snare diagram and indicated that torsion was experienced at the base of snare at the time of use.A section of the device did not remain inside the patient¿s body.The patient required an unknown additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: FDI, SNARE, FLEXIBLE
• 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 Key: 21196526
• Report Number: 1037905-2025-00065
• Device Sequence Number: 12837607
• Product Code: FDI
• UDI-Device Identifier: 00827002227002
• UDI-Public: (01)00827002227002(17)270607(10)W4843960
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 02/28/2025

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: G22700
• Device Catalogue Number: ASH-1-S
• Device Lot Number: W4843960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN COLONOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown