MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD. PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number BE9CS

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Seams appear to be splitting on multiple ge be9cs probes.

• Brand Name: PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD.
• MDR Report Key: 16504019
• MDR Text Key: 311045893
• Report Number: MW5115536
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE9CS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1