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

Catalog Number ASDB-25-015-S

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant: erbe electrosurgical generator - unknown model.Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report that the "duckbill shoots the other way." however, we determined that when retracting the device, resistance was encountered.When the device was received, the tip of the snare head was outside the distal end of the sheath and would not fully retract into the sheath.The handle of the snare was manipulated several times and the snare head eventually was able to retract into the sheath.When the snare head is fully extended, the snare head appears to be misshaped where the duck bill is formed.It is unknown when or how the duck bill became misshaped.The tip of the sheath exhibited some damage.There were several minor kinks throughout the length of the sheath.It is likely that the snare head being misshaped contributed to resistance felt when retracting the snare.A functional test was performed by placing the device down a pentax colonoscope (2.8 mm channel) and the colonoscope was placed in a curved position.The snare would open and close when the handle was manipulated.Upon closing the snare, resistance was felt.Resistance was mostly felt when the tip of the device was being retracted into the sheath.An additional functional test was performed by using an active cord from our lab stock.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.A meeting with production engineering and production management, indicated that the snare was slightly twisted, but the twisting was mostly due to the condition that the snare was received in.During the lab meeting, the snare head was formed into a duck bill shape.When the handle was manipulated the snare would advance and retract as intended with little resistance felt.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 includes the following to ensure proper use of the device: "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.Advance device, in small increments, until endoscopically viewed exiting endoscope.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 may cause fulguration of normal mucosa and/or perforation.Contact of snare wire with endoscope during electrosurgery 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 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 an endoscopic procedure, the physician used a cook acusnare polypectomy snare.When they tried to close the snare, the "duckbill" shoots the other way.Apparently, closing the snare does not function properly.Additional information received on 11/22/2017: the customer tells me that when they have the polyp in the snare and close the snare to cut it, the snare flips 180 degrees.After this happened, they noticed that the initial form of the snare changed and when you try to close it now, it flips 180 degrees.Additional information received on 11/28/2017: there was no abnormal resistance when retracting the snare.The device was evaluated on 11/28/2017: the snare will not retract fully into the sheath without some excessive pressure [resistance in snare retraction].The duck bill does not shoot the other way, however the snare head is a little misshapen which caused it to catch on the distal end of the catheter.

• 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: 7137374
• MDR Text Key: 96062512
• Report Number: 1037905-2017-00736
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226494
• UDI-Public: (01)00827002226494(17)200714(10)W3889846
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASDB-25-015-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: 11/13/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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