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

Model Number CYF-VH

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation the device failed the leak test due to a cut on the insertion tube.A deep scratch was found on the plastic and peeled glue around the objective lens.The bending section of the scope was detached from the body.The customer received a loaner device while the scope was being serviced.No other issues or injuries have been reported.If any additional information is obtained a follow up report will be filed.

Event Description

A user facility reported that a surgical scope failed the leak test during reprocessing.No patient involvement was reported.No additional information has been obtained.

Manufacturer Narrative

A device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.The root cause of the incident is unknown.Probable cause of the reported incident: since the distal end and bending section rubber were damaged, it is assumed that an external force was applied to the tip, resulting in damage.Due to the above damage, it is presumed that the glue peeling off the bending section rubber caused the leak to occur.In addition, since the date of manufacturing of the actual product is july 31, 2015, the damage of the tip part may be due to aging degradation.The suggested event is preventable in accordance with instruction for use: the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10370317
• MDR Text Key: 202102772
• Report Number: 8010047-2020-05302
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1