MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	G22700
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
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.The instructions for use contain the following information to assist with proper set-up and use of the device: "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode.Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure." "inspect active cord.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 active cord." "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit.Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode." 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.
Event or Problem Description
During a colonoscopy, a cook acusnare polypectomy snare was used.An olympus esg generator and olympus active cord was used for cautery to take out a polyp.The user started with the olympus generator and had to switch to an erbe generator with a cook active cord due to not being able to cauterize.With the erbe generator, cautery was still not possible, and they tried another snare as a result.The snare did not work with either esg system.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: KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): COOK ENDOSCOPY; 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: 13250462
• Report Number: 1037905-2022-00015
• Device Sequence Number: 14583082
• Product Code: KNS
• UDI-Device Identifier: 00827002227002
• UDI-Public: (01)00827002227002(17)240419(10)W4461972
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: 04/19/2024
• Device Model Number: G22700
• Device Catalogue Number: ASH-1-S
• Device Lot Number: W4461972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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: ERBE ICC 200 GENERATOR.; OLYMPUS CHF190 SCOPE.; OLYMPUS ESG GENERATOR.
• Patient Sex: Male