MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS, CORP. SNAREMASTER; ENDOSCOPIC SNARE FLEXIBLE

Model Number SD-221L-25

Device Problems Activation, Positioning or Separation Problem (2906); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

Olympus medical systems corp.: snaremaster from emr kit would not deploy.Deployment wire noted to be protruding from handle area.Fda safety report id# (b)(4).

• Brand Name: SNAREMASTER
• Type of Device: ENDOSCOPIC SNARE FLEXIBLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS, CORP.
• MDR Report Key: 8582486
• MDR Text Key: 144263726
• Report Number: MW5086385
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: SD-221L-25
• Device Catalogue Number: SD-221L-25
• Device Lot Number: 107394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 75 YR