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

Model Number UM-S20-17S

Device Problems Break (1069); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/27/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 272435489
• Report Number: 2951238-2021-00411
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2021,09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention