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 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings are reported.Physical evaluation of the complaint device reveals: the scope passed the water dunk test.It is confirmed, the rubber glue is cracking/peeling.There are no cracks on the ob lens, the image passed the fog test, there were no stains.The bending section was found to be dry with no looseness of the distal end.There were no cuts of crack on the video cable or connectors.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 of 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 d4 (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.A review of the instructions for use (ifu) shipped with the device provided the customer with the following information regarding the reported event: chapter 5 troubleshooting 5.1 troubleshooting warning ¿ never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage.¿ if any parts of the endoscope fall off inside the patient body due to equipment damage or failure, stop using the endoscope immediately and retrieve the parts in an appropriate way.Cyf-vh/vhr reprocessing manual chapter 5 reprocessing the endoscope 5.5 manually cleaning the endoscope and accessories dry external surfaces 2 inspect the endoscope for residual debris.Should any debris remain, repeat the entire cleaning procedure until all debris is removed.Conclusion: it is presumed that the foreign object, which remained inside the scope, was due to inadequate reprocessing and failure to fully follow the ifu.It was determined the issue was not due to a defect of the device or manufacturing process.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation per (b)(6).Based on the results of the further investigation, although there was a report of foreign matter falling off the forceps channel, the subject device was not used on a patient, nor related to any patient event.This supplemental report includes a correction to d8 from initial medwatch.Information added to d8 that was inadvertently not included on the initial medwatch.Also, h6 codes added.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: 11957524
• MDR Text Key: 273554618
• Report Number: 8010047-2021-07231
• 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: 02/03/2023

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: 04/17/2021
• 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
• Patient Sequence Number: 1