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

Model Number G22647

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: ors periop quality specialist pma/510(k) #: k191048.The medical facility provided information on this event to fda via submission of a medwatch report.Reference access number (b)(4) for information related to the same event that was provided to fda by the medical facility.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.The user indicated the device was used to cold snare.This device is intended to cauterize polyps.This is the most likely cause of the reported difficulties with cutting tissue.The intended use in the instructions for use (ifu) states: "this device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract." the instructions for use also states: "do not use this device for any purpose other than the stated intended 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 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 cold snaring was completed, 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.

Event Description

During a colonoscopy, the physician used an acusnare polypectomy snare.The cook acusnare polypectomy snare was deformed in the area adjacent to the opening/closing handle when being closed over tissue in the colon.Also when properly grounded and hooked to the erbe electrocautery machine in the room, the snare did not efficiently cut the tissue as expected (subject of report).There was no documentation of the event in the operative note.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved did not confirm the report.The device was returned with the snare head fully retracted inside the sheath.There was some deformation of the catheter at the proximal end, by the red end cap.The device was function tested by manipulating the handle, the snare head would advance and retract as intended.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.An additional functional test was performed by attaching the active cord to the electrical pin.The active cord connected to the device easily and remained securely connected.The device was connected to a valley lab generator and power was applied.The snare cut simulated tissue as expected.There were no other anomalies to report on this device.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 user indicated the device was used to cold snare.This is the most likely cause of the reported difficulties.The intended use in the instructions for use (ifu) states: "this device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.".The instructions for use also states: "do not use this device for any purpose other than the stated intended 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 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 cold snaring was completed, 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
• Type of Device: FDI, SNARE, FLEXIBLE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10757228
• MDR Text Key: 227955229
• Report Number: 1037905-2020-00462
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)230423(10)W4343222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: G22647
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4343222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL
• Patient Age: 68 YR
• Patient Weight: 94