MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Device Reprocessing Problem (1091)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The devices referenced in this report are not being returned to olympus for physical evaluation.The definitive cause for the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the journal article titled "what really works for scope reprocessing?", appearing july 2018 vol.39.No.7 of infection control and hospital epidemiology, that a retrospective study was conducted at a tertiary-care academic medical center with 401 beds to evaluate the impact of a multi-disciplinary team (mdt) with clear roles on the reprocessing of olympus duodenoscopes.During the baseline period between jan 2016 and june 2016, scopes were cultured after 9.4% of cases with a 40% positive culture rate (10 of 25 cultures).After establishing the mdt to increase efficacy of manual cleaning, during the intervention phase scopes were cultured after 20.3% of case with a positive culture rate of 4% (4 of 100 cultures) there was no reported patient contact/impact.

Manufacturer Narrative

This reported is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed as no serial number was provided.Olympus does not ship any device unless it meets all design and quality specifications.Conclusion: the definitive cause of the user's experience could not be determined.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10929699
• MDR Text Key: 227214400
• Report Number: 8010047-2020-09672
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1