MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

Model Number	G22649
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: company representative.Pma/510k: k191048.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a visual evaluation of the returned device, the snare head was retracted.However, since there is a severe bend on the distal end of the snare head, it would not fully retract and a portion is sticking out of the catheter.At the distal end of the handle, the catheter is collapsing due to the force of retracting the snare head.During a function test, the handle of the device was manipulated, the snare head would advance but not retract as intended.The snare head is severely bent, and the tip of the snare, the duck bill, is pointing inward.A lab meeting was held with manufacturing and engineering, no anomalies were detected with the device construction.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.This limits our ability to conclusively determine a cause.The instructions for use direct the user to: "fully retract and extend snare to confirm smooth operation of device." damage to the product can occur if the device experiences excessive pressure during use.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection.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 rare.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 endoscopic procedure to remove a polyp, the physician used an acusnare polypectomy snare.The device was opened and placed down the endoscope.When the user opened up the snare, the user noted that the tip was bent and subsequently the snare would not fully retract [subject of report].The user removed the entire device and set it aside.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.

• Brand Name: ACUSNARE POLYPECTOMY SNARE
• Common Device Name: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10678967
• Report Number: 1037905-2020-00434
• Device Sequence Number: 3449915
• Product Code: FDI
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)221230(10)W4302523
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 12/30/2022
• Device Model Number: G22649
• Device Catalogue Number: ASDB-25-015-S
• Device Lot Number: W4302523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1