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

Model Number CYF-VHR

Device Problems Contamination (1120); Degraded (1153)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found rust/corrosion inside the control body.In addition, during the angulation check, no movement was observed in the up/down direction, control knob was found to be stiff and heavy.This condition caused by the deterioration of the angulation mechanism due to rust.Furthermore, the following defects/findings were identified during device inspection: distal end (bending section) found detached.Crack observed on a-rubber (bending section) glue.Sharp dents observed on biopsy port.Huge leak found in the instrument channel.Moisture found inside a-rubber (insertion section).Scratches observed on video connector.Connector label peeled off.Device evaluation findings found rust/corrosion inside the device control body.It is probable that the "small black pieces that came out of the tool channel" as reported by the customer are from the rust/corrosion coming from the control body attributed due to degradation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported , small black pieces came out of the tool channel during an examination (diagnostic unspecified procedure).No harm was reported.No patient harm, no user injury reported.

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, the root cause could not be determined.Three attempts were performed to obtain additional information, but no response was received from the customer.Event 1: foreign material (black pieces) emerged from tool channel during examination.It was confirmed that the foreign material emerged from the tool channel, however, the specific material could not be identified and the cause for it remaining in the device could not be specified.Event 2: failure to move angulation.It is likely the event was caused by rust due to handling.The event can be prevented by following the instructions for use (ifu) which state: "caution 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.Also, do not bend, pull, or twist 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 inside the patient." olympus will continue to monitor field performance for this device.

• Brand Name: 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: 16433123
• MDR Text Key: 310327857
• Report Number: 3002808148-2023-01704
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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