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

Model Number GF-UCT260

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/31/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that after a reprocessing using an olympus automated endoscope reprocessor model oer-3 (not available in the usa), it was found that foreign material (it was seems like body fluid) were adhered under the forceps elevator.The subject device was loaner asset of olympus, the subject device was reprocessed after delivered to the facility.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon was duplicated.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.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for investigation.There was no abnormality such as adhesion of foreign material on the exterior of the subject device.As a result of overhaul inspection, there was no foreign material in the instrument channel, air/water channel, balloon channel and suction channel.The result of component analysis, main component of the foreign material was protein.Therefore, it was found that the foreign material was not parts and/or material derived from the subject device.Omsc concluded that the foreign material was derived from other than the subject device.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.

• Brand Name: EVIS LUCERA 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: 12056172
• MDR Text Key: 280574012
• Report Number: 8010047-2021-07924
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2011
• 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