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

Model Number CYF-V2R

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.As part of our investigation, on september 21, 2020, an endoscopic support specialist (ess) was dispatched to the user facility to follow up on the customer¿s concern.Also, the ess would observe the facility¿s reprocessing methods during this visit.The ess noted the following deviations during the reprocessing observation: scopes were not being leak tested nor fully submerged during manual cleaning and high level disinfection.In addition, more than the required chemicals for reprocessing were being used.The ess reported that the customer was advised on those issues and provided recommendations / education to complete reprocessing according to instructions.On september 22, 2020, the ess returned to the user facility and provided a complete reprocessing in ¿service which included demonstrating reprocessing steps according to the manufacturer¿s recommendations.The ess reported that the customer¿s questions related to the reprocessing workflow were addressed during this visit.The ess advised the customer leak testing must be performed and showed how using a third party leak testing device on site.The ess also provided the customer with the following additional recommendations: the use of a mu-1 / mb-155 to avoid fluid invasion in leaking scopes.Promoted the use of larger / adequately sized basins to perform manual cleaning with scopes fully submerged as well as high level disinfection with scope fully submerged.Advised against the use of chemicals over and above what is required as more chemicals in use can cause issues with residue and water quality.Advised against the use of wall hanging tubes for storage due to concerns they do not disinfect or allow the scope to air dry properly.The ess reported the customer was provided a copy of the reprocessing poster and confirmed the customer had ifu on hand for reference.The instruction manual states ¿after using this instrument, reprocess and store it according to the instructions given in chapter 5, ¿reprocessing: general policy¿ through chapter 8, ¿storage, transporting and disposal¿.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.¿.

Event Description

The service center was informed that a brown residue was noted on the scope¿s button on the left hand side.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Please see the updates in sections.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10673385
• MDR Text Key: 223663228
• Report Number: 8010047-2020-07632
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411212
• UDI-Public: 04953170411212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2R
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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