MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number OLYMPUS CYF-5

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/06/2018

Event Type  malfunction  

Event Description

Inspection of olympus cystoscopes with a borescope post reprocessing revealed black and red spots within the scopes.Brand new olympus scopes that were not yet used for patient care or reprocessed were also inspected and similar spots/markings were visible within these new scopes.Manufacturer response for cystoscopes, (brand not provided) (per site reporter).Olympus stated that they have received complaints from other device user facilities in the country regarding these same spots our facilities identified in the scopes.Olympus referred to these spots as "manufacturing details" but the manufacturer declined to put this in writing as a form of explanation.The manufacturer contends complaints correlate to the increase in the use of borescopes used by reprocessing facilities for scope inspections.It was also discussed with the manufacturer to send all scopes back to olympus for investigation; however, this was discouraged by the manufacturer since, as the manufacturer stated, the outcome will be the same with the markings still being present and visualized with a borescope.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8183896
• MDR Text Key: 131004225
• Report Number: 8183896
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: (01)04953170339417
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLYMPUS CYF-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1