• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION 30 DEGREE ENDO VIDEO SCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORPORATION 30 DEGREE ENDO VIDEO SCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number M3 30A
Device Problems Thermal Decomposition of Device (1071); Material Discolored (1170); Overheating of Device (1437)
Patient Problem Pain (1994)
Event Date 11/21/2019
Event Type  Injury  
Event Description

During cystoscopy procedure room staff noted they smelled something burning and pt moaned in pain so cystoscopy scope was removed. End of scope was blackened and scope body also had lighter colored black marks on shaft. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name30 DEGREE ENDO VIDEO SCOPE
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
MDR Report Key9391805
MDR Text Key168596612
Report NumberMW5091350
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM3 30A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/27/2019 Patient Sequence Number: 1
-
-