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

Catalog Number	ASDB-25-015-S
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned with the snare head advanced outside the distal end of the sheath.The snare head would not retract back into the sheath by handle manipulation.The handle of the device was manipulated to advance the snare head, and when the snare head was advanced outside the sheath, it was misshaped.The snare head did not form a uniform duck bill.When the snare head was advanced outside the sheath, the snare wire was bent above where the duck bill is normally formed.This created two (2) bends in the snare wire.One (1) that is made to create the duck bill shape, and one (1) that was bent during use; thus creating a misshaped snare head.The misshaped snare head contributed to the retraction difficulty that the user encountered.Further, when the snare head was retracted into the sheath, the additional bend in the snare wire prevented the snare head from full retraction.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill shape with one (1) bend in the distal end of the wire.The snare head smoothly advanced and retracted when manipulating the handle.When the snare head was fully retracted inside the sheath, the distance from the distal end of the snare wire to the distal end of the sheath met specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation of the snare wire that the cannula was not in the correct location and did not meet the specification.The position of this cannula could have contributed to the snare head becoming misshaped during use.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: the investigation determined that the devices did not meet manufacturing specification.During the manufacturing process for the forming wire, the cannulas were not placed at the correct location prior to being soldered to the forming wire.The operators were retrained on the manufacturing process.A field action request was initiated.A corrective action has been initiated to reduce occurrences for snare head retraction difficulties for 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.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 endoscopic mucosal resection (emr), the physician used a cook acusnare polypectomy snare.As reported to customer relations by the customer, "the snare wire crossed during a procedure and they were unable to fully close.They had to pull it out of the patient.It looks tangled." the following was received on 11/28/2018: emr was performed, and the snare was used by experienced staff.Upon retraction, the snare head became tangled and it was unable to close completely.A perforation occurred as a result.Hemostasis clips were placed and the patient was admitted for a hospital stay.During the hospital stay, a three-view x-ray was performed and confirmed free air, consistent with a perforation.A repeat colonoscopy was performed to repair the perforation with [additional] hemostasis clips.This occurred on three patients.See related mdrs 1037905-2018-00552 and 1037905-2018-00554.A section of the device did not remain inside the patient¿s body.The patient required placement of hemostasis clips, hospitalization and a repeat colonoscopy to place additional hemostasis clips to repair the perforation 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: 8115564
• Report Number: 1037905-2018-00553
• Device Sequence Number: 10811376
• Product Code: KNS
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)210606(10)W4070713
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K851958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2021
• Device Catalogue Number: ASDB-25-015-S
• Device Lot Number: W4070713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/29/2018
• 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: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention