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 Date 03/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that there was leaking at the distal end and on the bending section cover.Upon further inspection, it was observed that the adhesive on the distal end was missing due to user handling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the cysto-nephro videoscope had air/water leakage from the distal end.The reported issue occurred during preparation of use for a laparoscope procedure.The procedure was subsequently completed with a similar device.There was no patient/user harm or injury reported due to the event.Upon device return and evaluation, it was observed that the adhesive on the distal end was missing which, is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 adhesive on the distal end missing was due to incorrect handling of the device.The event can be detected/prevented by following the instructions for use which state: ¿[warnings and cautions] do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope 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: 16702990
• MDR Text Key: 313406231
• Report Number: 3002808148-2023-03506
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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
• Device Catalogue Number: N6006040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• 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