MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE; FLEXIBLE VIDEO CYSTONEPHROSCOPE

Model Number CYF-V2

Device Problems Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found leaking bending section rubber.Bending section rubber torn and adhesive removed and cracked bending section rubber glue.Insertion tube has faded marks, deep dent/faded markers.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the visera cysto-nephro videoscope bending rubber was damaged and metal protruded.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the air inside the endoscope expanded and the tip ruptured because the ethylene oxide cap was not attached to the vent connector during sterrad sterilization.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "when performing sterrad 100s/nx(with/without all clear technology) /100nx(with/without all clear technology) sterilization, the eto cap (mb-156) must be attached to the venting connector in order to avoid rupture of the bending section." olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO CYSTONEPHROSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16659294
• MDR Text Key: 312500287
• Report Number: 3002808148-2023-03220
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1