MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP CYSTO-NEPHRO VIDEOSCOPE; CYSTOSCOPE

Model Number OLYMPUS CYF-VH, CYF-V2 AND CYF-5

Device Problems Failure To Adhere Or Bond (1031); Crack (1135); Degraded (1153)

Patient Problem No Information (3190)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

There is adhesive/glue that is applied on the distal and proximal end of the bending rubber that can cause concern of cracking or gaps in the adhesive that seals the devices distal cap to its distal tip.It has been identified that degradation is occurring with the adhesive on olympus cystoscopes.So far, degradation has occurred in at least 54 olympus cystoscopes, which have only been reprocessed approximately 22-23 times.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 7244555
• MDR Text Key: 99126111
• Report Number: 7244555
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLYMPUS CYF-VH, CYF-V2 AND 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: 01/19/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1