MAUDE Adverse Event Report: WILSON-COOK MEDICAL ACUSNARE POLYPECTOMY SNARE SOFT

Model Number G22632

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

Event Type  malfunction  

Event Description

When removing a polyp using this snare and cautery the cautery stopped working in the middle of the polypectomy only burning half of the area.When we changed snares the cautery was working again.This product is defective because it did not adequately conduct electricity for cautery.No pt harm.

• Brand Name: ACUSNARE POLYPECTOMY SNARE SOFT
• Type of Device: POLYPECTOMY SNARE
• Manufacturer (Section D): WILSON-COOK MEDICAL; winston-salem NC
• MDR Report Key: 5167750
• MDR Text Key: 28949048
• Report Number: MW5057276
• Device Sequence Number: 1
• Product Code: KNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: G22632
• Device Catalogue Number: G22632
• Device Lot Number: W3607091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR