MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number BW-412T

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 03/08/2019

Event Type  malfunction  

Event Description

I was notified by a tech that the end of the scope brush fell off during manual cleaning.The missing piece was found in the sink.This incident happened twice.

• Brand Name: OLYMPUS
• Type of Device: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8443200
• MDR Text Key: 139550051
• Report Number: 8443200
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170297427
• UDI-Public: (01)04953170297427
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BW-412T
• Device Lot Number: V8926 AND V8907
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1