MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The endoscopy support specialists(ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide reprocessing training.To date, the ess visit has not been finalized.To date there was no patient harm or infection was reported.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the user site would not sterilize the scope for two days.According to the reporter when the user was performing bedside manual cleaning after the scope was used in a procedure, the scope is kept moist with an enzymatic spray.Sterilization is done off site and may not be completed until up to 2 days following the manual cleaning.According to the reporter, the user was unaware of any harm caused by their process.No patient impact or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), 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.It was reported that the user site would not sterilize the scope for two days.According to the reporter when the user was performing bedside and manual cleaning after the scope was used on a procedure, the scope is kept moist with an enzymatic spray.Based on the investigation results, per the reported description in which the endoscope has not been sterilized for two days after precleaning, manual cleaning and the endoscope was moistened with enzyme spray, it was highly likely that the subsequent sterilization process will be adversely affected.The process the user conducted should not be performed.Even though the correct procedure is to sterilize the endoscope immediately after performing manual cleaning, if immediate sterilization is not possible, after cleaning it is recommended to leave the instrument completely dry, not moistened because it is highly possible that subsequent sterilization can be effectively processed normally by drying the equipment.Olympus will continue to monitor complaints for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 10158214
• MDR Text Key: 223637675
• Report Number: 8010047-2020-03387
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/10/2020
• 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