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

Model Number UM-S20-17S

Device Problem Material Discolored (1170)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

The customer reported the ultrasonic probe turned black.The event occurred during preparation for use and the same device was used to complete the operation.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed.In addition, ultrasonic image disturbance and rotational failure of ultrasonic probe were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

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 8 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the ultrasonic medium is discolored black because the internal blade cannot be driven normally as the blade is buffered and the scraped metal pieces are collected at the tip in the insertion section sheath.The manufacturer has determined there is no potential for this complaint of the ultrasonic probe turning black to cause or contribute to an adverse event.The following information is stated in the instructions for use (ifu): "do not push the ultrasound probe with a strong force while the ultrasound probe is driven (freeze release) or pull it into the endoscope curvature.Pull the ultrasound probe slowly, especially when the endoscope is heavily curved or when the forceps is raised.Push and pull with strong force or sudden action may lead to image distortion or damage to the ultrasonic probe.When driving an ultrasound probe, return the endoscope to its curvature and forceps elevation as much as possible.Driving with severe probe geometry may lead to image disturbance or damage to the ultrasonic probe.".

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15194004
• MDR Text Key: 305244952
• Report Number: 3002808148-2022-00796
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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 Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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
• Treatment: EU-ME1 S/N (B)(6).MAJ-1720 S/N (B)(6).