MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Break (1069); Material Rupture (1546); Material Split, Cut or Torn (4008)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was evaluated.Device evaluation and inspection service repair found the bending rubber is blown and leaking and massive leakage was noted.In addition, the bending rubber (bending cover) adhesive was found detached.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported that the device bending end has ruptured and there are wires exposed.The issue found during reprocessing.There was no patient harm, no user injury reported due to the event.

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 (dhr) found no deviations that could have caused or contributed to the damaged/detached bending rubber (a-rubber).The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the following factors contributed to the event: 1.Sterilization with the sterrad machine was not properly performed because the ethylene oxide (eto) cap was potentially not attached to the device.As a result, unexpected air may have entered the device.2.The influx of air may have increased the pressure inside the device causing the a- rubber to rupture.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿3.1 compatibility summary: list of compatible methods validated in terms of microbiological efficacy and material durability: sterrad® 50/100s/200/nx¿: when performing sterrad® 50/100s/200/nx¿ sterilization, the sterilization cap (maj-1538) must be attached to the venting connector.¿ olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15189154
• MDR Text Key: 305006421
• Report Number: 3002808148-2022-00784
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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