MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACUSNARE POLYPECTOMY SNARE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22631
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an intestinal polyp removal, the physician used a cook acusnare polypectomy snare.It was reported [that the] user cannot open and close the snare inside the endoscopy channel smoothly.User detected the plastic outer sheath deformed while retracting the snare into sheath and the snare cannot be retracted completely into sheath.User then changed to another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.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
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos 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 photos describing the event.The first picture provided shows the package labeling, and the lot number/rpn match that in the report.The second picture shows the clear side of the pouch with the device in the coiled position.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: the additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy.Do not use this device for any purpose other than the stated intended use".This is the most likely cause of the report.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: a review of the complaint history was conducted.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that the user stated that a cold polypectomy was performed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white bag with an open pouch from the lot number provided in the report.The label matches the product returned.Photos were provided and reviewed.The first picture shows the clear side of the pouch with the device in the coiled position.The second picture shows the package labeling, and the lot number/rpn match that in the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned in a coiled position with the snare fully retracted and a reddish brown substance present throughout the catheter.There was a kinked/scrunched section present on the catheter from the base of the handle to approximately 3.2 cm.The device was functionally tested outside of the scope and the snare was able to advance and retract with minimal resistance.During additional functional testing, the device was advanced into the accessory channel of a pentax colonoscope (2.8mm channel) which was placed in a simulated lower gi position.The tip of the scope was retroflexed to simulate worst case scenario.With handle manipulation, the snare was able to advance/retract with significant resistance near the handle portion.A product discrepancy or anomaly that could have contributed to the 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 report.The additional information provided by the user stated that a cold polypectomy was performed.This is against the intended use of the device.The intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy.Do not use this device for any purpose other than the stated intended use." this is the most likely cause of the report.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: a review of the complaint history was conducted.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that the user stated that a cold polypectomy was performed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: KNS, 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 Key: 17143428
• Report Number: 1037905-2023-00299
• Device Sequence Number: 13926809
• Product Code: KNS
• UDI-Device Identifier: 00827002226319
• UDI-Public: (01)00827002226319(17)251019(10)W4647754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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 Expiration Date: 10/19/2025
• Device Model Number: G22631
• Device Catalogue Number: ASM-1-S
• Device Lot Number: W4647754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: ENDOSCOPE - UNKNOWN MAKE AND MODEL
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 75 KG