MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6R

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

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is likely due to mishandling and/or not reprocessing as identified within the instructions for use.The following verbiage is identified within the instructions for use reprocessing manual: "1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them".Multiple attempts were made to obtain the serial number however no response was able to be obtained or provided.If additional information is obtained a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 12399894
• MDR Text Key: 283249234
• Report Number: 8010047-2021-11038
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: URF-P6R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/18/2022
• 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