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

Catalog Number AS-1-S

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The device was returned with the snare head fully extended and the drive wire had disconnected from the handle. During a visual inspection of the drive wire, it appeared that the drive wire had not been torqued. An acusnare from our laboratory stock was disassembled at the handle spool to compare each drive wire. When the drive wire of the laboratory sample device was disconnected from the handle spool, the drive wire at the proximal end had an indention in the wire where the drive wire had been torqued. During the assembly process, the drive wire is placed through a brass insert within the handle spool and is torqued. There was not an indention on the drive wire of the complaint device, indicating most likely that the device was not torqued. The device will be sent back to the supplier. The product was returned to the approved supplier for evaluation and the investigation is on-going. Once additional information has been received, a follow-up emdr report will be provided.

Event Description

Prior to a polypectomy, the user selected a cook acusnare polypectomy snare. The user opened the package and checked the integrity of the device. They found out the handle was not working properly and the handle is disconnected from the device. There was no contact with patient. The user used another same product to complete the procedure. The user provided a photo of the device that showed the drive wire was disconnected from the handle. This occurred prior to patient contact; there was no impact to the patient.

• 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: 7812997
• MDR Text Key: 118540691
• Report Number: 1037905-2018-00377
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/26/2021
• Device Catalogue Number: AS-1-S
• Device Lot Number: W4025642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial