MAUDE Adverse Event Report: ESAOTE SPA E 3-12; ENDOCAVITY ULTRASOUND PROBE

Model Number	12000038
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Itching Sensation (1943)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injury has been reported.
Event or Problem Description
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

• Brand Name: E 3-12
• Common Device Name: ENDOCAVITY ULTRASOUND PROBE
• Manufacturer (Section D): ESAOTE SPA; via melen 77; genoa, italy 16152 ; IT 16152
• Manufacturer Contact: daniela leveratto ; via melen 77; genoa, italy 16152 ; IT 16152
• MDR Report Key: 21856955
• Report Number: 3012981490-2025-00001
• Device Sequence Number: 4695759
• Product Code: ITX
• UDI-Device Identifier: 08056304453891
• UDI-Public: 08056304453891
• Combination Product (Y/N): N
• PMA/510(K) Number: K230179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 12000038
• Device Catalogue Number: E 3-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown