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

Model Number URF-P7R

Device Problem Device Reprocessing Problem (1091)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the user's reprocessing method differed from that of the device instructions for use (ifu).The following is included in the ifu and may have helped prevent the event: "this manual contains the reprocessing methods recommended by olympus for the endoscopes and accessories listed on the front cover." "this instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively." "before reprocessing, thoroughly review this manual and the manuals for the reprocessing equipment and chemicals that will be used for reprocessing.Reprocess all the devices as instructed." olympus will continue to monitor field performance for this device.

Event Description

During an onsite reprocessing in-service visit, the olympus endoscopy support specialist (ess) became aware that the customer uretero-reno fiberscope was reprocessed incorrectly / insufficiently.The facility was not using a validated reprocessing method as the facility was running the scope through the medivators dsd edge and using rapicide pa.No death, injury or infection was reported.

Manufacturer Narrative

The ess provided a reprocessing in-service on pre-cleaning, leak testing, manual cleaning, and sterilization.The instructions for use were reviewed to go over the validated reprocessing method.Steps to complete sterilization were reviewed including which tray to use and how to use the sterilization cap.The customer was informed that should discontinue use of high-level disinfection with the urf-p7 endoscopes.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.

• 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: 14682914
• MDR Text Key: 300464182
• Report Number: 8010047-2022-09972
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403835
• UDI-Public: 04953170403835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Treatment: MEDIVATORS DSD EDGE; RAPICIDE PA