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

Catalog Number ASH-1-S

Device Problems Failure to Conduct (1114); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.During a visual inspection of the returned devices the sheath of the device was kinked/bunched together is two different spots.The first spot was near the handle from 0 cm - 2 cm.The second kinked area was located at 53.7 cm to 55.9 cm from the distal end of the handle.The head of the snare was very miss shaped and twisted.During a functional test the handle was manipulated and the snare would deploy and retract with some resistance felt, possibly due to the bunching of the catheter.The device was put through an endoscope and the endoscope was put the a worse case tortuous path and the snare was able to deploy and retract, still with some resistance felt.A functional test was performed on the acusnare.The active cord would connect 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 states: visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.The instructions for use states: "fully retract and extend snare to confirm smooth operation of device." the instructions for use states: "inspect active cord.Cord must be free of kinks, bends, breaks, and exposed wires to allow for accurate transfer of current.If an abnormality is noted, do not use active cord." the instructions for use states: "with electrosurgical unit off, prepare equipment.Securely connect active cord to device handle and electrosurgical unit.Active cord fittings should fit snugly into both device handle and electrosurgical unit.Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit." the instructions for use states: "advance snare wire out of sheath and position it around polyp to be removed.Warning: when applying current, tissue must be isolated from surrounding mucosa.Failure to isolate tissue may cause fulguration of normal mucosa and/or perforation.Contact of snare wire with endoscope during electro surgery may cause grounding, which could result in injury to patient and/or operator as well as damage to endoscope and/or snare wire." 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 actions: 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 (ash-1-s).As reported to customer relations: "today the physician used the ash-1-s snare.The physician was able to get it around the polyp/tumor but it would not release nor cut/coagulate.The physician finally had to "tug¿ fairly hard because it [the snare] was hard to get it out.Several places looked like it was twisted.¿.

Event Description

The following was initially reported to the fda on (b)(6) 2017: "during a colonoscopy procedure, the physician used a cook acusnare polypectomy snare (ash-1-s).As reported to customer relations: "today the physician used the ash-1-s snare.The physician was able to get it around the polyp/tumor but it would not release nor cut/coagulate.The physician finally had to "tug¿ fairly hard because it [the snare] was hard to get it out.Several places looked like it was twisted.¿ a medwatch report mw5073227 was received on 11/28/2017: "snare would not release polyp from tumor/polyp during colonoscopy.The polyp was snared, closed, coag [coagulation] set at 18, snare would not release or cut through.No harm to patient was noted.Diagnosis or reason for use: colonoscopy, rectal mass.".

• 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: 6254395
• MDR Text Key: 65028443
• Report Number: 1037905-2017-00026
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002227002
• UDI-Public: (01)00827002227002(17)180928(10)W3629176
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/06/2017,12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASH-1-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2017
• Distributor Facility Aware Date: 12/22/2016
• Device Age: 13 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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 COLONSCOPE (UNKNOWN MODEL)