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 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that the reported phenomenon could not be duplicated.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.However, based upon the information from the inspection result there was the possibility that the reported phenomenon was attributed to the following.The detergent solution might have remained in the channel due to the insufficient rinsing the channel while the cleaning of the subject device.Therefore, it was considered that while the sterile water was aspirated during the inspection before use for following procedure using the subject device, the remaining detergent solution in the channel and the sterile water were mixed, consequently they bubbled.Furthermore it was considered that the subject device was reprocessed and the remaining detergent solution was rinsed when the reported phenomenon occurred or before the inspection at omsc, therefore omsc could not duplicate the reported phenomenon.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, the suctioned liquid bubbled in the channel of the subject device.The subject device had been reprocessed with olympus automated endoscope reprocessors model oer-3 and oer-5 (both not available in the usa).There was no report of patient injury associated with the event.

• 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: 11913231
• MDR Text Key: 273548226
• Report Number: 8010047-2021-06959
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2021

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: No Information
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2021
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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