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

Model Number	G22647
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k191048.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.The instructions for use contains the following information to assist with proper set-up and use of the device: "inspect the active cord.The cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use the active cord." the instructions for use states the following system preparation warnings: "with the electrosurgical unit off, prepare the equipment.Securely connect the active cord to the device handle and electrosurgical unit.The active cord fittings should fit snugly into both the device handle and electrosurgical unit." the instructions for use also states the following potential complications: follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper selection, placement and utilization of the patient return electrode.Ensure that a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." system preparation warnings: "fully retract and extend snare to confirm smooth operation of device.The instructions for use, warning section also states: slide the adjustable marker, located in handle, to establish a reference point indicating full retraction of the snare into the sheath and to set up reference points for establishing the thickness of tissue being excised.The instructions for use states these potential complications: do not use this device with an output higher than the rated voltage 2.0 kvp-p (1000 vp) for cut mode and 5kvp-p (2500 vp) for coagulation mode.The instructions for use further states: do not use this device with an active cord which has a maximum voltage rating less than 5kvp-p (2500 vp).This could cause thermal injury to the patient, operator or assistant.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 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 polypectomy in the colon, the physician used a cook acusnare polypectomy snare and stated that it would not cauterize.They were able to successfully complete the procedure with a different snare.A section of the device did not remain inside the patients 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: 10992985
• Report Number: 1037905-2020-00549
• Device Sequence Number: 703825
• Product Code: FDI
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)230507(10)W4346126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 05/07/2023
• Device Model Number: G22647
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4346126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ESG150 ELECTROSURGICAL GENERATOR; OLYMPUS PCF-PH190L ENDOSCOPE