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

Model Number GF-UCT180

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus repair center in (b)(6) for repair.The evaluation of the device by olympus repair center confirmed the following; the water-resistant cap was twisted.The surface of the ultrasonic transducer was damaged and electrical safety could not be secured.The reported event appeared to be caused by physical stress due to dropping or hitting on a hard surface or object.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus inspected the device at olympus repair center in (b)(6) and found that the ultrasound acoustic lens on the probe unit was broken and rubber parts of the ultrasound acoustic lens were missing.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp.(omsc).The instruction manual of the device provides preventive measures against the reported failure mode.Omsc concluded that the reported event may have been caused by damage to the ultrasound acoustic lens due to external forces during transportation, storage, use and cleaning, etc.The reported failure mode by observing the instruction manual of this device can be prevented, so it may be caused by the user's handling.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 10982074
• MDR Text Key: 220673352
• Report Number: 8010047-2020-10174
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1