MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number	UM-S20-17S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported by the customer, an unspecified procedure was performed using an ultrasonic probe.The procedure went great.Once the probe was removed from the patient it was taken to the reprocessing room, where it was noticed that the radial transducer (tip) was missing from the probe.The probe is stretched about 12 inches longer than their new one, and is much thinner.The sheath that the transducer sits in is not broken.An x-ray was performed on the patient and the transducer was not seen inside the patient.The customer confirmed there was no harm to the patient.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12503467
• Report Number: 2951238-2021-00411
• Device Sequence Number: 20123776
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• Report Date (Section F): 08/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention