MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE160-AL5

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed.As noted in, a deep cut was discovered in the pink probe coating causing the device to leak.Additionally, the acoustic lens was cut.Further findings include a crack/leak at the control unit as well as severe damage (scratches, cuts, and perforations) on the insertion part of the device.It was also noted that the ultrasonic universal cord and connector were both damaged.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned their olympus ultrasonic gastrovideoscope due to the device experiencing a leak.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.During the device evaluation, it was discovered that the probe unit had a deep cut reaching under the coating material.This report is being submitted to capture the cut in the coating material noted during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.It has been over 7 years since the subject device was manufactured.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 legal manufacturer's investigation, the complaint was confirmed and an acoustic lens surface cut was also found.Multiple damages were confirmed at the tip, so it was surmised that an external force was likely applied to the tip.However, the cause could not be identified.It was assumed, however, that wear and tear damage with customer mishandling could have contributed to the event.Other events were also found: leakage of grip unit; perforated connection tube; light guide cover lens is damaged; scratches on the image guide cover lens; a-rubber - cementing defect; connection tube is broken; scope cover is cracked; scope body is cracked; grip unit is cracked; damage to universal cord; ultrasound-corrosion of connectors; angulation wire play.The instruction manual identifies the following related verbiage which indicates that the phenomenon could have been likely prevented: ¿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: olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 21-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13053269
• MDR Text Key: 282580127
• Report Number: 8010047-2021-16519
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356261
• UDI-Public: 04953170356261
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051541
• 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,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 11/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• 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