MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHR

Device Problem Crack (1135)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the scope passed the water dunk test.There were minor scratches on the plastic cover.It was confirmed, the rubber glue was cracked/peeling exposing thread.The ob lens glue was missing.The lg lens had minor scratches.All required repairs were completed and the device was shipped back to the customer meeting safety specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in mw5101053, after reprocessing a cysto-nephro videoscope, black specks were noted.There is no reported patient contact/impact related to this occurrence.In mw5101053, this facility reports 6 cases.Report with patient identifier (b)(6) reports case 1 of 6 report with patient identifier (b)(6) reports case 2 of 6 report with patient identifier (b)(6) reports case 3 of 6 report with patient identifier (b)(6) reports case 4 of 6 report with patient identifier (b)(6) reports case 5 of 6 report with patient identifier (b)(6) reports case 6 of 6.

Manufacturer Narrative

This report is being updated to report corrected information.Corrected data is reported in serial number.

Manufacturer Narrative

This report is being updated to report investigation findings.Device history record (dhr)/service history review: a dhr review has been performed for this product and determined that there were no nonconformance's during the manufacturing process of this device.Conclusion summary: olympus could not identify the definitive root cause of the reported event.[observations] we confirmed the following: we confirmed that this case was about ¿the black foreign material fell¿ inside the patient¿s body.There was no detailed descriptions of the fallen foreign material.According to the device inspection results, it was confirmed that the adhesive on the a-rubber was cracked, the distal end was damaged, and there were scratches on the lens.It could not be determined whether the damage was caused by stress or handling.As a result of checking the manufacturing record, it was determined the subject device was shipped as a good product (no design or safety non-conformities) it was uncertain if there was a relevance between the fallen material and each part of the damaged scope.Sterrad sterilization was adopted in the re-processing of the device, but it was uncertain if there was a relevance to the reported event or not.From the above, it is unclear whether the black foreign matter seen was due to the damage found on inspection, or whether it is caused by insufficient sterilization from the sterrad automated scope reprocessor.Due to these factors, the root cause could not be identified.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation per capa-200413.Based on the results of the further investigation, the subject device (cyf-vhr sn: (b)(6)) was not used on a patient, nor related to any patient event.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11957466
• MDR Text Key: 281516324
• Report Number: 8010047-2021-07229
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: CAPA-200413
• Patient Sequence Number: 1