MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5

Model Number CYF-5

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/06/2018

Event Type  malfunction  

Event Description

Olympus flexible cystoscope used in operating room procedure (second stage buccal urethroplasty w/suprapubic catheter placement).Scope was intact at start of procedure but when removed after use, about 3 cm of its covering was missing, exposing metal mesh.Field was searched and all pieces were accounted for.No known injury to pt.

• Brand Name: OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5
• Type of Device: OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS; 3500 corporate pkwy ; center valley PA 18034 0610
• MDR Report Key: 7533527
• MDR Text Key: 108982500
• Report Number: MW5077343
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• 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