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 Type  malfunction  

Event Description

It was observed that during the device evaluation, the ultrasound gastrovideoscope exhibited knob wire had foreign objects.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found that due to wear of angle wire, bending angle in up direction does not meet the standard value; adhesive on bending section cover had detached and discoloration; low angulation and free play due to deformation of bending tube; connecting tube had dent and wrinkles; image guide protector had cut; leakage from electrical connector and ultrasound connector; universal cord had a scratch; due to damage on charged coupled device unit, the image had black dots; due to damage on charged coupled device unit, the specified resolving power was not obtained; scope cover had a scratch; due to deformation of ultrasonic connector, water tightness was lost; due to a scratch on acoustic lens, it had a snag on it; due to wear of angle wire, the play of upward/downward angulation control knob was out of the standard value; light guide lens had a scratch; grip had a scratch; suction cylinder had a scratch; distal end had stain; no angulation when angulation control knob was turned; switch box had a scratch; due to clogging of nozzle, water removal ability does not meet the standard value.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the foreign material was insufficient cleaning which the user deviated from the instruction manual.Identification of the material could not be determined.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: 18615893
• MDR Text Key: 334264102
• Report Number: 3002808148-2024-00965
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2013
• 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