MAUDE Adverse Event Report: GE GE LOGIQ E9 ENDOCAVITY ULTRASOUND PROBE

Model Number IC5-9-D

Device Problems Break (1069); Material Separation (1562); Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 01/26/2017

Event Type  malfunction  

Event Description

Ge endocavity ultrasound probe issue consisting of broken seal gap and burr identification.Five separate veteran affairs medical center sterile processing departments have reported a line of separation between the probe tip and handle and a "burr" at the distal tip.The issue was first reported by the (b)(6).

• Brand Name: GE LOGIQ E9 ENDOCAVITY ULTRASOUND PROBE
• Type of Device: ENDOCAVITY ULTRASOUND PROBE
• Manufacturer (Section D): GE
• MDR Report Key: 6348975
• MDR Text Key: 68151513
• Report Number: MW5068003
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2017

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
• Device Operator: Health Professional
• Device Model Number: IC5-9-D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1