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

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).

• Brand Name: 30 DEGREE ENDO VIDEO SCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 9391805
• MDR Text Key: 168596612
• Report Number: MW5091350
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3 30A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 104