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

Model Number CYF-VHR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this case was not returned to olympus for physical evaluation.An olympus field representative compared the complaint scope to another manufacturer's scope in the field and noted that the insertion tube outer diameter of the olympus scope is 0.5mm bigger than other manufacturer's cystoscope and the distal end of the olympus scope is smaller (8.1fr) compared to the other manufacturer's scope (10.9fr).Additional information regarding the patients/event is being pursued.At the time additional relevant details becomes available and/or at completion of the investigation, this report will be updated accordingly.

Event Description

It is reported that two physicians have mentioned that the olympus cysto-nephro videoscope is bigger than another manufacturer's scope making it more traumatic to navigate in patients with urethral stenosis, and this lead to increased bleeding and tearing in a couple of cases.No additional information is available at this time.There was no report of any device malfunction.

Manufacturer Narrative

This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the specific complaint device could not be reviewed as the serial number could not be provided.Olympus ensures all devices meet all design and quality specification before shipping.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: 3.1 the workflow of preparation and inspection 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.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5,"troubleshooting".If this endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, "returning the endoscope for repair".Conclusion: the definitive cause of the user's experienced cannot be determined.No device issue was identified.It is possible that the reported event may have occurred due to the handling of cyf-vhr or to the site of the lesion when cyf-vhr was used.

• 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: 10747664
• MDR Text Key: 213428451
• Report Number: 8010047-2020-08222
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other