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

Model Number CYF-V2

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was repaired and returned to the customer.This mdr is being submitted retrospectively as a part of the remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The device was returned to an olympus service center for evaluation.During the evaluation of the device, it was observed that the bending section covering was coming off of the bending section.There was no patient involvement, as the issue was identified during service.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and device evaluation results.The device was returned to the service center for evaluation.The estimation evaluation found missing bending section rubber and the bending section glue cracked.The distal end plastic scope cover was found dented.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.Confirmed that there was no variation.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: the legal manufacturer speculated that the external force applied to the bending section rubber resulted in the missing.The current product has been manufactured on september 25, 2019 for about one year.For this reason, it is unlikely that this phenomenon is affecting deterioration.However, it is speculative that there is no delivery of the current product or attachment of a photograph of the broken part.The legal manufacture referred to chapter 3 preparation and inspection before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 9.3, "returning the endoscope for repair" on page 123.If any irregularity is observed after inspection, follow the instructions given in chapter 9, "troubleshooting".Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

• Brand Name: VISERA 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
• MDR Report Key: 10963677
• MDR Text Key: 226924455
• Report Number: 8010047-2020-09986
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1