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

Model Number GF-UCT180

Device Problem 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 inspected at olympus (b)(4).Olympus (b)(4) confirmed the reported phenomenon which may have caused by insufficient cleaning.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 olympus (b)(4), it was found there was the foreign object on the forceps elevator of the subject device.The subject device had been returned to olympus (b)(4) for repair of the angle malfunction of the bending.The occurrence date of the event is unknown.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not identify the root cause of the reported phenomenon.[consideration].Based on the investigation result, the phenomenon occurred seemingly due to adhesion of foreign material during procedure as nozzle clogging was confirmed during the inspection of olympus india.The information below was obtained from the investigation.-forceps elevator has foreign material.-cracks and scratches in objective lens.-bending rubber glue chipped.-damage on insertion section.-boot part breakage.-switch or switch box damages.-cable damage.-low angulations.-angulation play -imager breakage.-black dots in image (black scratches).-image blur due to damage on ccd unit.-nozzle clogging during inspection.-damage on distal end.-damage on acoustic lens.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.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: 12973249
• MDR Text Key: 282841381
• Report Number: 8010047-2021-15849
• 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: 02/22/2022

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 Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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