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 Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The snare was returned with the snare head advanced outside the distal end of the sheath.The snare head would not retract back into the sheath by handle manipulation.The handle of the device was manipulated to advance the snare head and when the snare head was advanced outside the sheath, it was misshapen.The snare head did not form a uniformed duck bill.When the snare head was advanced outside the sheath, the snare wire was bent above where the duck bill is normally formed.This created two (2) bends in the snare wire.One (1) that is made to create the duck bill shape, and one (1) that was bent during use; thus creating a misshapen snare head.The misshapen snare head contributed to the retraction difficulty that the user encountered.Further, when the snare head was retracted into the sheath, the additional bend in the snare wire prevented the snare head from full retraction.Additionally, the tip of the sheath exhibited some damage most likely as a result of the snare not fully retracting back into the sheath.The snare wire was manipulated with a pair of tweezers and formed back into a duck bill shape with one (1) bend in the distal end of the wire.The snare head smoothly advanced and retracted when manipulating the handle.When the snare head was fully retracted inside the sheath, the snare head was 19 mm from the distal end of the sheath.The distance from the distal end of the snare wire to the distal end of the sheath met specification.The sheath of the snare was disassembled from the handle to evaluate the formed snare wire.It was found during the evaluation of the snare wire cannula that is soldered to the snare wire was in the correct location and met specification.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 corrective action has been initiated to reduce occurrences for snare head retraction difficulties for asdb devices.The product said to be involved is included in the scope of the corrective actions.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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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 mucosal resection (emr), the physician used a cook acusnare polypectomy snare.The tip [snare head] was not pulling into the sheath [unable to retract].They were unable to cut the polyp.Per the user, the device "twists like the other devices that were reported." see mdrs 1037905-2018-00552, 1037905-2018-00553 and 1037905-2018-00554 for previously reported devices.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
• 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: 8250139
• MDR Text Key: 133247597
• Report Number: 1037905-2019-00019
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002226470
• UDI-Public: (01)00827002226470(17)210207(10)W4026875
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Catalogue Number: ASDB-15-015-S
• Device Lot Number: W4026875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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