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

Model Number CYF-VH

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation and the reported issue was confirmed.There was a channel leak.The bending section rubber was worn and had scratches.The evis image was foggy/blurry.The body had corrosion and scratches.The video cable had a minor dent.The scope connector had a loose end to open (eto) valve and the video connector had minor scratches.An olympus endoscopy support specialist (ess) has been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training if necessary, to correct and address any reprocessing deviations.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that a second leak test was performed on the cysto-nephro videoscope the day before and the scope had passed the leak test, however, a brown rust type liquid was coming from the tip of the scope even after a brush was run through it.It is unknown if it was a microorganism.The issue was found at reprocessing.The scope was reprocessed on (b)(6) 2021.The scope was not eto sterilized.The scope was put through the oer-pro after being hand washed.All reprocessing personnel were trained on how to properly reprocess an endoscope.No patient harm was reported.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and an update on the olympus endoscopy support specialist (ess) in-service.The ess attempted to contact the customer to schedule an in-service to observe the user facility¿s reprocessing practices, but was unsuccessful, therefore no in-service will be conducted at this time.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.No foreign matter could be identified.There were water / air leaks from the forceps channel, which may have indicated scratches or holes inside the forceps channel.The root cause of the issue could not be conclusively specified, therefore, the following were possible causes: due to the damage inside the forceps channel, cleaning at the facility after the case was insufficient, and the patient's tissue at the time of the case could not be completely cleaned and remained.Powder applied during the manufacturing process entered the inside through scratches and holes formed in the forceps channel and mixed with water such as the cleaning liquid used during the reprocessing and leaked as foreign matter.

• 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
• MDR Report Key: 11620257
• MDR Text Key: 244035624
• Report Number: 8010047-2021-04658
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALTH LAB BIO-ZYME ENZYMATIC CLEANER; LEAKAGE TESTER, MODEL # MB-155, S/N # 7853801; OER-PRO, S/N # 2733932; SINGLE USE COMBO CLEANING BRUSH, MODEL # BW-411B; HEALTH LAB BIO-ZYME ENZYMATIC CLEANER; LEAKAGE TESTER, MODEL # MB-155, S/N # 7853801; OER-PRO, S/N # 2733932; SINGLE USE COMBO CLEANING BRUSH, MODEL # BW-411B