MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

The service center was informed that a customer evis exera ii ultrasound gastrovideoscope was returned due to a report of "leakage at the plug" that was observed during reprocessing.However, upon inspection and testing, the scope was found to have a (reportable) probe malfunction as a portion of the pink colored coating of the acoustic lens on the probe unit was scratched off and missing.No patient involvement or harm was reported to olympus.

Manufacturer Narrative

The service inspection found a probe malfunction as a portion of the pink colored coating of the acoustic lens on the probe unit was scratched off and missing.The customer reported issue was confirmed as the scope connector was leaking.Also the scope is leaking from the body control unit.Additionally, the bending section cover glue is peeling (leaving a gap), the switch box unit, the light guide lens, the up/down knob, universal cord and air/water nut have cosmetic wear.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

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 legal manufacturer's investigation, multiple scratches were found at the distal end, and it is seemingly due to external force applied to the distal end.However, the cause of it could not be identified.The instruction manual identifies the following related verbiage which may help prevent the phenomenon: ¿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.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND 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: 12939533
• MDR Text Key: 286565673
• Report Number: 8010047-2021-15593
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• 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