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

Model Number GF-UCT180

Device Problems Material Separation (1562); Failure to Clean Adequately (4048)

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

Event Date 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the following were found during the evaluation; due to wear of grip, water tightness is lost; there is a gap between acoustic lens and ultrasound probe; and the light guide bundle has breakage.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the ultrasound gastrovideoscope had a gap of adhesive on the distal end / stain entered inside the lens through the gap.There is a gap between acoustic lens and ultrasound probe.There were no reports of patient involvement.

Manufacturer Narrative

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, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.As result of confirming instruction manual, it was found that cautions were described about phenomenon.Instructions evis exera ii ultrasound gastrovideoscope olympus gf type uct180.Important information - please read before use ¿ "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient".¿ "do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged".¿ "do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result".¿ "do not twist or bend the bending section with your hands.Equipment damage may result".¿ "do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks".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: 19117747
• MDR Text Key: 341260234
• Report Number: 3002808148-2024-03539
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• 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
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• 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