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

Model Number URF-P6

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

An olympus employee observed a deviation in cleaning, handling and incorrect reprocessing of uretero-reno fiberscopes by the tiger team.The scope was left on the case for several hours prior to transport to sterile processing department (spd) for manual cleaning.There was no harm, infection or user injury reported due to the event.This event is related to patient identifiers: (b)(6).

Manufacturer Narrative

The olympus employee observed dirty scopes were left in the case tray waiting to be transported to sterile processing department (spd) for cleaning for over an hour.The scopes used in the morning were not transported to spd for manual cleaning until the end of the day.The olympus employee documented the cleaning, disinfection, and sterilization process for the devices.The customer was instructed to follow all olympus reprocessing procedures.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.Updates to section.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined that the user facility did not train reprocessing staff sufficiently on handling and reprocessing in accordance with information for use.(ifu).Additionally, it was confirmed that there was cleaning delay, wrong handling and transportation.The scope was on the table with other instruments stacked on it post procedure scope was left on the case cart for several hours prior to being transported to spd for manual cleaning.Ess recommended the user to follow all the olympus reprocessing process, described in on track form, and reprocessing ifu.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.If the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside immediately after each patient procedure.

• 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: 12571634
• MDR Text Key: 280938498
• Report Number: 8010047-2021-12664
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• 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