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

Catalog Number	ASDB-15-015-S
Medical Device Problem Codes	Retraction Problem (1536); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: one (1) device from the lot number said to be involved was returned in an opened pouch and does not appear as if it has been used.Ten (10) additional devices from the lot number said to be involved were returned in sealed pouches.The user did not return the one (1) used device.Our laboratory evaluation of the open-pouch product said to be involved could not confirm the report as it was described.The handle of the device was manipulated and the device would open and close as intended.There were no kinks or bends in the sheath found throughout the device.The device was inspected with the snare head retracted inside the sheath and the distance from the distal tip of the sheath to the distal tip of the snare wire was documented.The device measured within the specified tolerance.A second measurement of the device was taken from the distal tip of the snare wire to the proximal end of the soldered cannula, and the device measured within the specified tolerance.A functional test was performed on the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected successfully to an active cord.The device was connected to a valley lab generator and power was supplied.The snare cut and cauterized the simulated tissue.The snare head remained uniform during the functional test.Sealed devices 1 - 8.Our laboratory evaluation of the sealed products said to be involved could not confirm the report as it was described.Each device handle was manipulated, and each device would open and close as intended.There were no kinks or bends in the sheath found throughout each device.Each device was inspected with the snare head retracted inside the sheath, and the distance from the distal tip of the sheath to the distal tip of the snare wire measured within the specified tolerance.A second measurement was taken on each device from the distal tip of the snare wire to the proximal end of the soldered cannula, and each device measured within the specified tolerance.A functional test was performed on each device.The continuity from the electrical pin to the snare head was tested on each device with an ohm meter and passed.Each device was tested by connecting an active cord to the devices.Each device was connected to a valley lab generator and power was supplied.Each snare cut and cauterized the simulated tissue.The snare head of the devices remained uniform during the functional test.Sealed device 9.Our laboratory evaluation of one (1) of the sealed-pouch devices from the lot number said to be involved could not confirm the report as it was described.The handle of the device was manipulated and the device would open and close.When the device was closing, the snare would bend the opposite direction prior to being fully retracted into the sheath of the snare.There were no kinks or bends in the sheath.The device was inspected with the snare head retracted inside the sheath, and the distance from the distal tip of the sheath to the distal tip of the snare wire measured within the specified tolerance.A second measurement of the device was taken from the distal tip of the snare wire to the proximal end of the soldered cannula, and the device measured within the specified tolerance.A functional test was performed on the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected successfully to an active cord.The device was connected to a valley lab generator and power was supplied.The snare cut and cauterized the simulated tissue.The snare head remained uniform during the functional test.Sealed device 10.Our laboratory evaluation of the one (1) of the sealed-pouch devices from the lot number said to be involved confirmed the report.The handle of the device was manipulated and the device would open and close as intended.There were no kinks or bend in the sheath.The device was inspected with the snare head retracted inside the sheath, and the distance from the distal tip of the sheath to the distal tip of the snare wire measured within the specified tolerance.A second measurement of the device was taken from the distal tip of the snare wire to the proximal end of the soldered cannula and measured within the specified tolerance.A functional test was performed of the device.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected successfully to an active cord.The device was connected to a valley lab generator and power was supplied.When power was being supplied, when the snare was being retracted into the sheath, the snare head became stuck on the simulated tissue.The snare wire became misshaped and the tissue was not removed successfully.When the snare head was removed from the simulated tissue, the snare head would no longer fully retract back into the distal end of the sheath.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 corrective action has been initiated to reduce occurrences for snare head retraction difficulties for acusnare polypectomy snare (asdb) devices.The product said to be involved is included in the scope of the corrective actions.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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.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 procedure, the physician used a cook acusnare polypectomy snare.As reported to customer relations "the device would not close properly around the polyp.It could not snare the polyp from the tissue.They were able to successfully complete the procedure with another device.This happened in three separate procedures with three separate patients on the same day with the same lot number." (see related mdrs 1037905-2018-00337 and 1037905-2018-00338 for the two additional events) the following was received on 03-july-2018: we have had a recurring problem with deformation of the crescent acusnare (15 mm) [asdb-15-015-s].With a straight endoscope position but a large amount of tissue, the physician had two (2) snare failures.One (1) had a hard time cutting through [the tissue] (subject of this report).In the second [event], the physician had to abandon and switch to a stiff oval snare (see related mdr 1037905-2018-00337).The physician then had a third patient who experienced the same issue.It was failure of the 15 mm crescent snare [asdb-15-015-s] to close (see related mdr 1037905-2018-00338).The user had to abandon [the device] and switch to another snare after using a bunch of electrocautery.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, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7728589
• Report Number: 1037905-2018-00336
• Device Sequence Number: 11029128
• Product Code: KNS
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)210417(10)W4053662
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 04/17/2021
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4053662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1