MAUDE Adverse Event Report: OLYMPUS CORP OF AMERICA OLYMPUS CYSTOSCOPE

Model Number CYF-5

Device Problem Material Disintegration (1177)

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

Event Date 05/23/2017

Event Type  Injury  

Event Description

During a procedure, the sheath of the cystoscope was noted to be disintegrating.Pre-procedure checks reportedly did not indicate any problem with the material.The problem was noticed after the device was removed from the patient.After inspection, it was determined that no pieces of the sheath remained in the patient.Date returned to olympus approximate.

• Brand Name: OLYMPUS CYSTOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS CORP OF AMERICA
• MDR Report Key: 6766696
• MDR Text Key: 81914813
• Report Number: MW5071354
• 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: 07/27/2017

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: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: 6515-438658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2017
• 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 Outcome(s): Required Intervention