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

Model Number CYF-5R

Device Problems Device Reprocessing Problem (1091); Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

Endoscopy support specialist (ess) visited the user facility site.Ess met with the (surgical service director) to discuss the concern with staff in the or (operating room) not knowing how to properly pre clean prior to transporting scopes to sterile processing where reprocessing is completed.There has been a lot of turnover with or department staff and the current staff members either do not know how and or were not confident in proper pre cleaning recommendations.After the discussion , the ess completed an in service with lead sterile processing tech/facility verifier on the pre cleaning steps from the olympus reprocessing manual and on track to be able to train or staff in proper pre cleaning.In addition, a follow up email was sent to the surgical service director and lead sterile processing technician which included olympus reprocessing manuals and ontrack check lists.This report will be supplemented accordingly following investigations.

Event Description

As reported ,the user facility site lead sterile processing technician and surgical services director requested an onsite service training as facility or (operating room) staff do not know how and or were not confident in proper pre cleaning of the scopes prior to transporting scopes to sterile processing where reprocessing is completed.Staff as reported, have never been trained to perform pre-cleaning.There was no patient involvement associated on this reported event.No patient infection associated on this reported event.No user injury reported.This report is related to a report with patient identifier (b)(6).

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation and information gathered, the staff is cleaning without knowing the correct pre-cleaning method.In addition, it was confirmed that the phenomenon was not caused by the product or the manufacture, and that there were no abnormalities with the safety.Customer was already guided to implement pre-cleaning.Based on investigation and conclusion, it was assumed that the phenomenon was caused by use error.As stated on the ifu (instruction for use) the user manual states: 7.3 precleaning preclean the endoscope at the bedside in the procedure room immediately following the procedure.These steps are to be performed when the light source is turned off.If the endoscope is not immediately precleaned, residual organic debris will begin to solidify, and it may be difficult to effectively reprocess the endoscope.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
• MDR Report Key: 12399325
• MDR Text Key: 270074035
• Report Number: 8010047-2021-11035
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170328817
• UDI-Public: 04953170328817
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1