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

Catalog Number	SASM-1-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: valley lab electrosurgical generator.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 states: "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." the instructions for use states: "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." the instructions for use states: "advance snare wire out of sheath and position it around polyp to be removed.Warning: when applying current, tissue must be isolated from surrounding mucosa.Failure to isolate tissue may cause fulguration of normal mucosa and/or perforation.Contact of snare wire with endoscope during electrosurgery may cause grounding, which could result in injury to patient and/or operator as well as damage to endoscope and/or snare wire." prior to distribution, all 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 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 an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acusnare polypectomy snare soft.The snare frayed after they removed the polyp leaving a black char on the tissue.Based on the additional questions answered by the area representative the device allowed cutting, but did not coagulate/burn properly.The following clarification was received on 3/22/17: it [the frayed snare] did not form a sharp point.

• 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: 6478113
• Report Number: 1037905-2017-00154
• Device Sequence Number: 582287
• Product Code: KNS
• UDI-Device Identifier: 00827002226333
• UDI-Public: (01)00827002226333(17)200116(10)W3818126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: SASM-1-S
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2017
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: FUJINON 106-8620 ENDOSCOPE