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

Model Number CYF-VHR

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.In addition to the reportable malfunction documented in b5, the additional evaluation findings are as follows: scope leak test was unable to see for additional leaks, and the control body had fluid and corrosion in the body control unit.According to the cds provided on the quality inspection results, the item had been cleaned, disinfected, or sterilized before returning to olympus for evaluation.The investigation is ongoing and 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 that the videoscope had an air/water leak.The issue was observed during reprocessing of an unspecified therapeutic procedure.There were no reports of patient or user harm associated with this event.The device was returned to olympus for a device evaluation.During the evaluation, the following reportable issue was found: the insertion tube was leaking, cut below boot.There were no reports of patient or user harm associated with this event.This mdr is being submitted to capture reportable malfunction found during the device evaluation.

Manufacturer Narrative

This supplemental report is being submitted 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.The device was returned to olympus for evaluation.The customer's allegation was confirmed.Based on the results of the investigation, a definitive root cause could not be established.The event can be detected and prevented by handling the device in accordance if the instructions for use which state: ¿ do not coil the insertion tube, universal cord, or video cable with a diameter of less than 10 cm.Equipment damage may result.¿ do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.¿ do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end.Visual abnormalities may result.¿ if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found.In this case, stop using the endoscope, and contact olympus.¿ do not twist or bend the bending section with your hands.Equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.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: 18443919
• MDR Text Key: 331986382
• Report Number: 3002808148-2024-00106
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310522
• UDI-Public: 04953170310522
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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: 12/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2012
• 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