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.

• 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
• MDR Report Key: 15902235
• MDR Text Key: 304676262
• Report Number: 2429304-2022-00146
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2022,12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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?: Yes
• Distributor Facility Aware Date: 11/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 96 KG