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

Model Number	CYF-V2R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.During the evaluation the device was leak tested and no leaks were observed.The reported issue was confirmed, the scope had a hole in it and the cap was broken.A replacement device was shipped to the user facility.In addition, as part of the investigation into this report,olympus followed up with the user facility to obtain more information and was informed the issue was noticed during reprocessing.The scope was taken out of the sterilizer and it was noticed that when they opened the cap the end of the scope had blown out.The cap was still on the scope.However, when they opened the cap it was noticed the camera part had blown out.A new cap has been ordered.The device has been sent to olympus for repair.No other damage or abnormalities were observed when the scope was inspected after the two issues were noticed with the scope.The service order number is (b)(4).There was no patient involvement.This one scope was the only one that had damage.The sterilizer being used is an asp sterad x.This sterilizer is new.The scopes are leak tested prior to every procedure.The leak tester is an olympus leak tester model wa23080a.Enzymatic detergent is being used to manually clean and disinfect the scopes.It is unknown how often the minimum effective concentration is being checked.The endoscope channel is being brushed with an olympus bw-7b brush.Pre-cleaning is being done immediately after a procedure.Air is flushed into the endoscope.The last time a reprocessing in-service was provided was 3 years ago.However, their processing and infection control come every year to watch them clean the scopes.All reprocessing personnel are trained on how to reprocess the scopes.The scopes are being stored in their sterile container when not in use.The user facility continues to reprocess the scopes following manual instructions.If additional information is obtained a follow up report will be submitted.
Event or Problem Description
The user facility reported that parts fall off from the distal end of the scope.The scope has a hole, and the eto cap was broken.
Additional Manufacturer Narrative
D4: the serial number of the device was updated from (b)(6) to (b)(6).The letter a was used to mark the device as a refurbishment.H6: a device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.After the device evaluation, the event was determined to be caused due to the mishandling of the device.Per the instructions for use: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.Exceeding the recommended parameters may cause equipment damage.Do not seal the endoscope with other equipment that may contact the endoscope in the package.Otherwise, the endoscope may be damaged.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: 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: 10201296
• Report Number: 2951238-2020-00460
• Device Sequence Number: 16797718
• Product Code: FAJ
• UDI-Device Identifier: 04953170287619
• UDI-Public: 04953170287619
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1