MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Failure to Clean Adequately (4048)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported, that the gastrovideoscope dripped black fluid after being cleaned and disinfected due to being incorrectly reprocessed.The issue occurred during reprocessing.There were no reports of patient involvement.

Manufacturer Narrative

D8: was inadvertently selected.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d8, and d9.Additional information added to field: h3, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction of scope dripping black fluid after cleaning and disinfection was confirmed.Based on the results of the investigation, it is presumed that black fluid dipping from the scope which was cleaned and disinfected was likely due to leakage from the biopsy or instrument channel (bx channel) which led to insufficient reprocessing and the foreign object could not be removed.The presumed cause for adhesive around the forceps covers missing could not be specified.However, a definitive root cause could not be determined.As a result of confirming the contents of the instruction manual about shipping products, there are detailed explanation of reprocessing in the items below.Chapter 7 cleaning, disinfection, and sterilization procedures chapter 8 reprocessing workflow for endoscopes and accessories chapter 9 reprocessing the endoscope (and related reprocessing accessories) three attempts were performed to obtain additional information, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18995422
• MDR Text Key: 339335653
• Report Number: 3002808148-2024-02968
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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