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

Model Number CYF-V2

Device Problems Material Disintegration (1177); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was received by olympus for evaluation.The user facility report was confirmed and the insertion sheath was found to be damaged.If new and/or additional information is provided following repair activity, a summary will be provided in a supplemental report.

Event Description

The user facility reported that the black outer sheath is disintegrating, breaking, falling off and metal is showing in multiple places.The reporter did not confirm patient involvement but no patient harm was reported.Olympus has made multiple attempts to gather additional information for this report with no response received to date.

Manufacturer Narrative

The supplemental report is being submitted to provide the results of the manufacturer's investigation.A review of the device history record (dhr), and review of the instructions for use (ifu), and an evaluation of the device were completed as part of this investigation.Results of the device evaluation are provided in the initial report.Further, it was found that air leaks from the insertion tube and universal cord, the universal cord is damaged, the mesh parts of the insertion tube are exposed but not protruding, and the a-rubber is torn and fell off.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: "chapter 3 preparation and inspection before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 9.3, ¿returning the endoscope for repair¿ on page 123.If any irregularity is observed after inspection, follow the instructions given in chapter 9, ¿troubleshooting¿." "using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage." the root cause could not be established.It has been about one year since the device was manufactured when the complaint event was reported, so it is unlikely that the device was affected by aging and deterioration of the a-rubber.A possible cause includes external force applied to device.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA 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: 10373320
• MDR Text Key: 201878669
• Report Number: 8010047-2020-05334
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1