MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE160-AL5

Device Problem Failure to Clean Adequately (4048)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported, the gastrovideoscope experienced water channel will not clean due to clogging.The issue occurred during reprocessing.The intended procedure was completed with the same device without delay.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and the evaluation found the nozzle was clogged.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information received from customer on reprocessing.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, the foreign object could not be identified.The cause of the foreign object residue in the device could not be identified.Information on reprocessing: the customer does not know what the foreign material is or when the foreign material was adhered to the device.Pre-cleaning information: the device was manually cleaned by the customer.According to the instruction manual at the time of shipping the product, there are descriptions as to reprocessing below.Chapter 6 "compatible reprocessing methods and chemical agents" chapter 7 "cleaning, disinfection and sterilization procedures" chapter 8 "cleaning and disinfection equipment" olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC 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: 18807729
• MDR Text Key: 337633119
• Report Number: 3002808148-2024-01910
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• 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