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

Model Number CYF-VH

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, leakage at the distal end of the cysto-nephro videoscope was noted during reprocessing.The device was returned and an evaluation at the repair center revealed, the bending section cover was missing.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no patient involvement.

Manufacturer Narrative

An evaluation of the returned device confirmed the customer allegation.Leakage was noted at the insertion tube and bending section cover.The device failed the insulation test.Insulation failure of the insertion section (distal end cover and insertion tube) was noted.The adhesive of the bending section cover was peeling.The insertion tube had a cut and the metal inside the insertion tube was visible.The light guide tube had scratches.The video connector was cracked.The control knob was deformed.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 of the missing mending section and adhesive peeling could not be determined.The event can be detected/prevented by following the instructions for use which state: ¿warning ¿ 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: 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 (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: 16635168
• MDR Text Key: 312227133
• Report Number: 3002808148-2023-03101
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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