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

Model Number GF-UE160-AL5

Device Problems Gas/Air Leak (2946); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the ultrasonic gastrovideoscope had air leakage from the switch key top.There was no patient/user harm or injury reported due to the event.

Manufacturer Narrative

At this time olympus has not received this device back for testing and evaluation.Should the device be returned, an evaluation will be completed, and a follow up report will be submitted.

Event Description

Upon device return and evaluation, it was observed that the nozzle was clogged by foreign material which is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation, and it was uncovered that the nozzle was clogged by unidentified, white-colored foreign material.The foreign residue resembled a cleaning agent that could not be removed.This finding was due to insufficient cleaning or handling of the scope.Upon further inspection, it was observed that the rubber of switch button one is pierced and leaky.It was also observed that the charge-coupled device cover lens was chipped.It was observed that the acoustic lens of the probe unit had cuts.Additionally, it was observed that the piezo elements of the probe unit were defective.It was also observed that the control unit¿s scope body was damaged.It was observed that the universal cord was kinked.Lastly, it was observed that the insulation value at the distal end was out of specification.This report is also being submitted to provide additional information based on the legal manufacturer's final investigation.Section b5, d8, d9, and h3 were updated with additional information that was received about the event.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 definitive root cause of the foreign material could not be identified.Considerations ¿ 1) during a follow-up with the customer, the customer confirmed that the facility followed the instructions manual and the national regulations however, no information or reprocessing observations were conducted to confirm if the reprocessing methods were carried out properly.2) upon inspection from the repair department, there was no abnormality on the device at the nozzle.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: 17740945
• MDR Text Key: 323333047
• Report Number: 3002808148-2023-09803
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356261
• UDI-Public: 04953170356261
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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