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

Model Number G22629

Device Problem Material Disintegration (1177)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the snare retracted into the sheath.The device opened and closed as intended when the handle was manipulated, however during a visual inspection the ends of the wires looked frayed.The frayed area has come apart at the tip of the device.The frayed ends look charred, as if heat was applied to them.The snare head was made of a braided wire (multiple strands wrapped around a core wire).A portion of the strand broke at one point along the snare wire.It is unknown when or how the wires became frayed.Due to availability an asmh-1 snare from our lab stock was used to simulate a situation where the snare head makes contact with a metal surface.The asmh-1 used for testing is made of the same material as the as-1-s complaint device.The snare tip was placed on the grounding pad and the wires slowly frayed.The device was tested at a low setting.There was no debris left on the grounding pad due to the wires fraying, however we cannot confirm that no tiny portions of the device that was used were left in the patient.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 charring along the wire and the damage could be a result of the snare wire contacting the endoscope during electrosurgery.The instructions for use contain the following warning: "contact of snare wire with endoscope during electrosurgery may cause grounding, which would result in injury to patient and/or operator as well as damage to endoscope and/or snare wire." prior to distribution, all acusnare polypectomy snare soft are subjected to a visual inspection and functional test to ensure proper workability.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 rare.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 Description

During a polypectomy procedure, the physician used a cook acusnare polypectomy snare.The user reported that when court [current] was being done [applied] with the polypectomy handle in the procedure, the wire of the [device] broke from the tip [tip of snare head detached].There was no complication to the patient.No part of the device was left inside the patient.They decided to use another new snare.The device was received for evaluation.The snare head did not detach, however the distal tip of the snare was no longer connected.The investigation could not rule out that no small portions had disintegrated and/or detached.The initial reporter stated that a section of the device did not remain inside the patient¿s body, however; the investigation could not rule out small missing disintegrated and/or detached pieces.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
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT 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: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8855201
• MDR Text Key: 153167624
• Report Number: 1037905-2019-00435
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226296
• UDI-Public: (01)00827002226296(17)220320(10)W4194003
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: G22629
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4194003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS 190 GASTROSCOPE
• Patient Age: 58 YR