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

Model Number CYF-VHR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The scope was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during reprocessing the distal end of the scope was noted to be shredding.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d8, g3, g6, h2, h6, and h10.The subject device has not been returned to olympus for evaluation.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred because the distal end was subject to an impact by an external force due to handling.In addition, the subject device may have been affected by the aging deterioration because it has been more than 15 years since manufacturing.Confirmation of the contents of the instruction manual is identified below: "do not strike, hit, or drop the endoscope's distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off into the patient".

• 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: 11595875
• MDR Text Key: 243342962
• Report Number: 8010047-2021-04404
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1