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

Catalog Number ASDB-15-015-S

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a visual inspection of the returned snare there was a kink in the sheath near the distal end of the handle.The kink was located from 2.1 cm to 3.2 cm from the handle.A second kink was observed near the distal tip.The kink was located at 6.8 cm from the distal tip of the device.During a functional test with the device outside of an endoscope the snare head advanced and retracted as intended.The device was then placed down a 3830 tl pentax colonoscope (2.8 mm channel).The scope was placed in a straight position.When the handle of the device was manipulated the snare head would advance and retract without resistance as intended.The colonoscope was then placed in a curved position to demonstrate a worst case scenario.The handle of the device was manipulated and resistance was encountered with advancing and retracting the snare head.It was observed that when retracting the snare head with the colonoscope in a curved position that the sheath near the handle would begin to bunch up.It is most likely that the resistance felt by the user was due to the kink near the handle.An additional functional test was performed outside the endoscope.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The active cord would connect and remained securely connected without any issues.The device was connected to a valley lab generator and power was applied to cut simulated tissue.The snare cut the simulated tissue as intended.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.The instructions for use states: "if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinds, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use directs the user to: "fully retract and extend snare to confirm smooth operation of device." the instructions for use directs the user to: "advance device, in small increments, until endoscopically viewed exiting endoscope." damage to the product can occur if the device experiences excessive pressure during handle/preparation.Prior to distribution, all acusnare polypectomy snares are subjected to a visual inspection.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

In preparation for a procedure, the user selected a cook acusnare polypectomy snare.The catheter is compressing/shrinking close to the handle when closing the snare and applying pressure before resecting the polyp.According to the customer the sheath of the snare is too soft.There was no reportable at this time.Additional information was received on 02/27/2018: if the forceps [snare]/handle is pulled, the catheter inverts (after about 2 cm) together.The catheter is folded/compressed by the pressure, about 2 cm after the handle.There was no reportable information at this time.The device was evaluated on 03/15/2018.It was determined that the snare was difficult to retract.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7407666
• MDR Text Key: 105379015
• Report Number: 1037905-2018-00139
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)200123(10)W3818308
• Combination Product (y/n): N
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASDB-15-015-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• 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