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

Model Number G22702

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the device was kinked and there was resistance when retracting.The device returned with a brown liquid inside the tubing and the snare fully retracted.It was noted that the sheath was bunching/kinking from the base of the handle to 2 cm distal of the handle, this bunching/kinking likely resembled a "melted" area to the user.During a dimensional inspection, it was noted that the sheath was flattened at 99 cm from the distal end of the handle to 99.5 cm.There was also a kink at 227.5 cm from the distal end of the handle.When the handle was manipulated, the snare advanced and retracted; however, there was slight resistance when retracting.A functional test was then performed by advancing the device through a pentax ec-3830tl colonoscope (2.8 mm channel).The endoscope was placed in a curved position to simulate a worst case scenario.The handle of the device was manipulated and the snare head advanced and retracted, however some resistance was felt.A functional test was performed on simulated tissue with the acusnare.The active cord connected easily and remained securely connected.The continuity from the electrical pin to the snare head was tested with an ohm meter and passed.The device was connected to a valley lab generator and power was applied.The snare cut the simulated tissue as expected.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 direct the user to: "fully retract and extend snare to confirm smooth operation of device.Note: if using an acusnare, slide adjustable marker, located in handle, to establish a reference point indicating full retraction of snare into sheath and to set up reference points for establishing thickness of tissue being excised." the instructions for use state: "advance device, in small increments, until endoscopically viewed exiting endoscope." damage to the product can occur if the device experiences excessive pressure during use.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 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 Description

During a colonoscopy procedure, the physician used a cook acusnare polypectomy snare soft.When they hit the foot pedals (hot snare), it started to melt the top of the catheter by the handle.They used another snare from the same lot to complete the procedure successfully.There was no reportable information at this time.The device was received for evaluation on 14-mar-2019.The sheath was not melted, but kinked at the base of the handle.There was some resistance in retracting the snare.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 SOFT
• 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: 8492942
• MDR Text Key: 144530688
• Report Number: 1037905-2019-00183
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227026
• UDI-Public: (01)00827002227026(17)211220(10)W4159776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2021
• Device Model Number: G22702
• Device Catalogue Number: SASH-1-S
• Device Lot Number: W4159776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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