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

Model Number	G22629
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.
Event or Problem Description
During an unknown procedure, the physician used a cook acusnare polypectomy snare.It was reported [that] the lis [snare head loop] does not want to unfold [advance].The [drive] wire is not correctly attached to the handle.This is interpreted to mean that the handle cannula separated from the handle.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.
Additional Manufacturer Narrative
This follow-up report is being submitted due to confirmation received on 12/06/2022 that patient was not adversely impacted.
Event or Problem Description
During an unknown procedure, the physician used a cook acusnare polypectomy snare.It was reported [that] the lis [snare head loop] does not want to unfold [advance].The [drive] wire is not correctly attached to the handle.This is interpreted to mean that the handle cannula separated from the handle.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: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare retracted beyond the distal tip of the catheter.When the handle was manipulated, the snare would not advance or retract.During a visual inspection, the handle cannula was retracted and the drive wire was exposed in the handle slot.A close visual examination of the proximal end of the handle cannula showed an indentation indicating that it had been crimped; however there was no evidence of indentation to show that the drive wire had been torqued.A function test was not possible, due to the condition of the device.The product was returned to the supplier for further evaluation and the following was provided, "the device was returned with the proximal end of the drive wire/pushrod assembly outside the handle stem.When the handle was manipulated, the snare tip would not advance or retract.Due to the snare tip not advancing when the handle was manipulated, further functional evaluations could not be performed.Our laboratory evaluation of the product said to be involved confirmed the report.When the handle was manipulated, the snare tip would not advance or retract.The root cause for the snare tip not advancing is the handle loop not being attached to the drive wire/push rod assembly.The drive wire/push rod assembly was examined under magnification.There are no visible markings or indentations to indicate that the handle loop was attached to the drive wire/push rod assembly nor tightened appropriately in the manufacturing process.The device history records were reviewed and there are no relevant defects noted in the manufacturing/qc checklist.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 supplier provided the following, "the complaint was confirmed.The assignable cause has been determined to be human error.Operators will be advised of the complaint and retrained." 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.

• 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: 15920758
• Report Number: 1037905-2022-00655
• Device Sequence Number: 6535449
• Product Code: KNS
• UDI-Device Identifier: 00827002226296
• UDI-Public: (01)00827002226296(17)250708(10)W4615103
• Combination Product (Y/N): N
• PMA/510(K) Number: K851958
• 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): 01/31/2023

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: 07/08/2025
• Device Model Number: G22629
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4615103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 01/06/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/16/2022; 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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 Sex: Unknown