MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

Model Number EU-ME1

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the reported issue is unknown at this time.In a follow up response on october 31, 2022, it was noted the customer has confirmed that no additional procedures were involved only the endoscopic procedure.Additional follow ups were made regarding the event reported , however, no response is received from the customer.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported the device processor crashed four (4) times (screen blacked out) when user had a needle in a patients node.The issue occurred during a therapeutic endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure.According to the report, the intended procedure was completed using the same set of equipment.No delay in the procedure was reported.There was no patient harm or injury reported.No user injury reported.

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 11 years since the subject device was manufactured.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Correction: the manufacturer has determined there is no potential for this issue of the ultrasound image blacking out while the needle was being inserted into the patient¿s node to cause or contribute to an adverse event.

• Brand Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Type of Device: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• 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: 15704324
• MDR Text Key: 303230110
• Report Number: 3002808148-2022-03732
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04953170355639
• UDI-Public: 04953170355639
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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: EU-ME1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2011
• 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