MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-3R-3

Device Problem Break (1069)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned, it was observed, visual inspection found wrinkles when the appearance was checked.Actual machine confirmation could not reproduce the reported issue.After connecting and operating according to the instruction manual, no abnormalities were confirmed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, during maintenance, the ultrasonic probe had defective image.Upon inspection of the customer¿s returned device it was observed, breakage of the insertion tube was noted.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 18 years since the subject device was manufactured.Based on the results of the investigation, it is likely the puncture occurred because there was a trace like a forceps bite in the puncture part in the sheath of the distal end.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿[warnings] do not grasp the ultrasound probe with sharp instruments.It can lead to infection and damage of the ultrasound probe.[cautions] do not push the ultrasound probe with strong force or pull it into the curvature of the endoscope while the ultrasound probe is driven (unfreeze condition).In particular, slowly push and pull the ultrasound probe when the endoscope is strongly curved or on instruments.Pushing and pulling with strong force or sudden action may result in image disturbance or ultrasonic probe damage.When driving the ultrasound probe, return the curvature of the endoscope or on the instruments as much as possible.Driving with a harsh probe shape can result in image disturbance and ultrasonic probe damage.In endoscopes with a forceps table, be sure to fall the forceps table before pulling out the ultrasound probe.Pulling the forceps table up may break the ultrasound probe.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16584813
• MDR Text Key: 312203543
• Report Number: 3002808148-2023-02792
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170063213
• UDI-Public: 04953170063213
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-3R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1