MAUDE Adverse Event Report: USENDOSCOPY / /STERIS CORPORATION HISTOLOCK SNARE; SNARE, FLEXIBLE

Model Number 00711117

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

An emr was performed by the fellow with a histolock snare.Malfunctions include; the snare kinking multiple times during emr which created a shortage in the erbe, making the emr inadequate.During an emr, there was a malfunction with the histolock snare made by steris.There was a kink in the histolock when trying to close the snare.This caused a shortage in the erbe, making the cautery to not go through all the way.We had this issue twice, with 2 histolock snares.

• Brand Name: HISTOLOCK SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): USENDOSCOPY / /STERIS CORPORATION
• MDR Report Key: 11562467
• MDR Text Key: 242430223
• Report Number: MW5100226
• Device Sequence Number: 1
• Product Code: FDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00711117
• Device Lot Number: 1912249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR