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

Model Number GF-UE260-AL5

Device Problems Material Split, Cut or Torn (4008); Failure to Clean Adequately (4048)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

During the device evaluation, it was observed that the ultrasonic gastrovideoscope's probe unit had a deep cut that reached to the hard part under the pink probe.Foreign debris was also found protruding from the air/water nozzle.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and there were no other findings other than the two reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information received from the 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 root cause of the foreign object residue remaining in the device could not be identified.However, a definitive root cause could not be determined.In addition, it is likely that handling of the device at the facility caused the event to occur.However, a definitive root cause could not be determined.The reprocessing procedures are described in the following chapters.These possibly prevent phenomenon (1).Chapter 6 "compatible reprocessing methods and chemical agents" chapter 7 "cleaning, disinfection, and sterilization procedures" according to the instruction manual as to handling of the actual product, there is the following description.Based on this, it is possible to be able to prevent phenomenon (2)."do not apply shock to the distal end of the insertion tube, particularly the ultrasonic transducer and the objective lens surface at the distal end.This could cause abnormalities in the visual and/or ultrasonic images"."do not hold the ultrasonic transducer when holding the insertion tube.The ultrasonic transducer damage can result and/or the ultrasonic image will be abnormal".Information on reprocessing: in general, our customer was trained by olympus for processing practice in accordance with ifu.¿ when this device came into the repair center for inspection, the customer did not provide any information regarding failure and/or issues on the reprocessing practice.¿ as this repair order is nothing to do with hmi nor patient infection, the customer is not willing to provide any information for the reprocessing practice to olympus.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: 18761687
• MDR Text Key: 337072421
• Report Number: 3002808148-2024-01663
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE260-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2009
• 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