MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-G20-29R-3

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation of the device confirmed the followings; the oil came out of the distal end.The sheath of the distal end was torn.There was a dent at the distal end of the sheath.Due to the damage to the sheath of the distal end, the ultrasound image of the endoscope was not extracted normally.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc guessed that the reported event was caused by the damage to the sheath of the distal end due to external stress.If additional information becomes available, this report will be supplemented.

Event Description

The customer noticed that oil came out of the distal end of the device at preparation for use.The customer was preparing the device because they were going to use it for intraluminal ultrasonography (idus).Since the patient procedure did not require idus, the device was not used.Choledochoscopy was successfully completed instead.There was no report of patient injury associated with this event.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 04-aug-2020.Olympus will continue to monitor the field performance of this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• 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: 10912764
• MDR Text Key: 226134483
• Report Number: 8010047-2020-09538
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• 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