MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA ULTRASONIC PROBE; FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER

Model Number UM-S20-17S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/03/2022

Event Type  Death  

Event Description

The customer reports after an unspecified procedure for the indication of right upper lobe nodule/mass using five olympus devices, the patient died later that day of cardiac arrest unrelated to the procedure.Case with patient identifier (b)(6) reports device 1 of 5 (bf-1th190); case with patient identifier (b)(6) reports device 2 of 5 (um-s20-17s); case with patient identifier (b)(6) reports device 3 of 5 (bf-1th190); case with patient identifier (b)(6) reports device 4 of 5 (bf-xt190); case with patient identifier (b)(6) reports device 5 of 5 (bf-uc180f).There were no complications during the procedure using the olympus devices.No olympus device malfunctioned in any way during the procedure.The customer requested preventative maintenance be completed on all devices.

Manufacturer Narrative

This event has been reported by the importer on mdr# 2429304-2022-00146.The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.Physical evaluation of the returned device: visual inspection as received condition under a microscope found multiple scratches, scrape marks on the distal end.There was a bubble present in propagation fluid medium, but no medium leakage, and the flexible shaft appeared to be slightly stretched.Also, found a small pin hole and multiple scrape marks along the insertion tube.The damaged section of the working length was measured approximately 580mm from distal end.Observed that there are no abnormalities on the connector section.The ultrasound probe was then connected properly into the olympus test probe driving unit maj-1720 and checked with an endoscopic ultrasound center me-2.The frequency detection was working correctly and displayed 20mhz on the monitor screen.During initial functional inspection, the us image did not appear on the screen due to bubble present; however, after vigorously shaking the distal end until all air bubble had been eliminated from inside the transparent sheath section of the ultrasonic probe, the us image displayed on screen, but appeared to be blurry, and low resolution.The damage found on the working length is likely due mishandling.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This supplemental report is being submitted to correct the previously reported initial mdr, based on additional information, based on legal manufacturer's investigation.It was determined that the patient's outcome is unrelated to the use of the device, and that the device reportedly involved into this reported event did not malfunction.

Manufacturer Narrative

Correction: additional information based on the legal manufacturer's final investigation was inadvertently left out of the previous supplemental report.Additionally, there was no need to correct the initially reported event.H6 investigation and conclusion codes are being added.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: FLEXIBLE ENDOSCOPIC ULTRASOUND IMAGING TRANSDUCER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA; 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: 15901636
• MDR Text Key: 304676863
• Report Number: 3002808148-2022-04765
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/09/2022; 12/20/2022
• Supplement Dates FDA Received: 12/16/2022; 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 96 KG