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

Model Number UM-S20-17S

Device Problem Contamination (1120)

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

Event Date 07/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed and there was no other abnormality.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.

Event Description

The customer reported that blood contamination was noted at the tip of the ultrasonic probe.The event occurred during a postoperative reprocess, prior to a diagnostic endoscopic ultrasonography operation.The same device was used to complete the operation and there was no patient 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 (dhr) found no deviations that could have caused or contributed to the contamination (blood)/leakage of the ultrasonic medium.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the blood entered the device from a perforation at the tip of the sheath.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿chapter 4 operation 4.2 observation of the ultrasound image ¿ never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it.¿ do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation.¿ 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15138414
• MDR Text Key: 304802341
• Report Number: 3002808148-2022-00511
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

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: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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