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

Model Number GF-UCT180

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomena.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of (b)(4) it was found as follows.There was a foreign material on groove or gap of the distal end due to insufficient cleaning (handling problems).The ultrasonic transducer had deep cut that reached to the hard part under the pink probe coating due to physical stress such as dropping/knocking.There was crack on distal end cover (a gap had occurred) due to physical stress caused by handling.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. the exact cause of the reported event could not be conclusively determined because since no detailed information is available on the foreign material. the exact cause of the reported event could not be conclusively determined.Unable to determine the cause of the forceps cover glue peeling was attributed to whether the stress or user¿s handling, as though the way it damaged seemed similar to other damage.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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12867346
• MDR Text Key: 281223276
• Report Number: 8010047-2021-14997
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1