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

Model Number CYF-VH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the service center and is pending evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The service center informed that during reprocessing the lamination (glue) was note to be flaking off the distal tip of the scope.There was no report of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results and correct the device return date.Based on the evaluation, the original equipment manufacturer (oem) reported the following findings and probable cause.Findings: generation of scratches in the apical region.Absence of adhesive (both ends) resulting in detachment.Scratches occur on the illumination lens.Scratches are generated in the insertion section of the corrugated tube.A scratch occurred in the operating area.Kinks occurred in the light guide cable.Video cable scratches occur.Scratches occur in the video connector.The knob of the operation unit was damaged.The knob of the operation unit was damaged.(probable cause).Did not come to an investigation into the true cause of the incident.The oem speculated that there are the following possibilities: peeling of a rubber: cleaning agent caused the adhesive to peel off at both ends of bending section cover.The external force was applied to bending section cover, resulting in peeling.However, root cause could not be determined because the current product could not be checked.Other, occurrence of scratches: it is presumed that the scratch occurred due to handling." the instruction manual states in chapter 1 general policy ¿1.6 reprocessing and storage after use warning¿: do not reuse rinse water.Disinfectant solution is only effective when used according to the disinfectant manufacturer¿s instructions.Follow the manufacturer¿s instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve disinfection.If the disinfectant solution is reused, check its efficacy by proper methods, such as using a test strip, according to the disinfectant manufacturer¿s recommendations prior to use.Do not reuse alcohol.Alcohol is not a sterilant or high-level disinfectant.To maintain sterility of equipment following sterilization, use sterile packaging and wraps according to national guidelines." additional findings: from the dhrs (shipping exam records), it was confirmed that the current product was shipped under normal conditions.The physical device findings were provided to the oem: generation of scratches in the apical region.Absence of bending section cover adhesive (both ends) resulting in detachment.Scratches occur on the illumination lens.Scratches are generated in the insertion section of the corrugated tube.A scratch occurred in the operating area.Kids occurred in the light guide cable.Video cable scratches occur.Scratches occur in the video connector.The equipment satisfy the specifications:not performed as tier2.How the device was used in related events:this is the event that occurred when reprocess.Survey record:as a result of checking complaint basic information, there is no missing information.Comment to initiator / sales-bc:n/a.Classification of response:final.Remarks: n/a.Investigated by: (b)(4).Translated by: (b)(4).

• 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: 9937108
• MDR Text Key: 208976398
• Report Number: 8010047-2020-02057
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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