MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE SOFT; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number	SASMM-1-S
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: electrosurgical generator; unknown make or model and active cords; unknown make or model.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.Before using the acusnare, the instructions for use instruct the user to "securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit." before using the acusnare, the instructions for use instruct the user to "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow accurate transfer of current.If an abnormality is noted, do not use active cord." prior to distribution, all acusnare polypectomy snares soft 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.Concomitant medical products: electrosurgical generator; unknown make or model and active cords; unknown make or model 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.Before using the acusnare, the instructions for use instruct the user to "securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit." before using the acusnare, the instructions for use instruct the user to "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow accurate transfer of current.If an abnormality is noted, do not use active cord." prior to distribution, all acusnare polypectomy snares soft 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 a polypectomy, the physician used a cook acusnare polypectomy snare soft.As reported to customer relations: "when the device was hooked up to cautery it would not work." the following additional information provided was provided on, (b)(6) 2016: "no additional procedures or intervention was required.The technician used a new snare, a new active cord and a new electrosurgical generator to complete the procedure." the following information was provided from medwatch report ((b)(4)), received (b)(6) 2016: "md [physician] wanted to use "hot snare" (polypectomy with cautery) snare placed around polyp, but cautery would not work with the snare cautery machine.[the snare cautery machine was] used previously without problem so snare was switched.No harm to pt [patient].".
Additional Manufacturer Narrative
Concomitant medical products: electrosurgical generator; unknown make or model and active cords; unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The handle was manipulated and the snare head extended and retracted smoothly.A functional test was performed on the acusnare.The active cord would connect easily and remained securely connected.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was applied.The snare cut the simulated tissue as expected.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.Before using the acusnare, the instructions for use instruct the user to "securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit." before using the acusnare, the instructions for use instruct the user to "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow accurate transfer of current.If an abnormality is noted, do not use active cord." prior to distribution, all acusnare polypectomy snares soft 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 SOFT
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6037931
• Report Number: 1037905-2016-00417
• Device Sequence Number: 1797138
• Product Code: KNS
• UDI-Device Identifier: 00827002227040
• UDI-Public: (01)00827002227040(17)190824(10)W3761769
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017
• Report Date (Section F): 09/29/2016

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 Catalogue Number: SASMM-1-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2016
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 03/02/2017
• 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 ENDOSCOPE (UNKNOWN MODEL)
• Patient Age: 79 YR
• Patient Weight: 80
• Date Report Sent to FDA: 09/29/2016