MAUDE Adverse Event Report: GE GE IC5-9D; IC5-9D TRANSVAGINAL US PROBE

Model Number 5194434

Device Problems Crack (1135); Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2017

Event Type  malfunction  

Event Description

Ge transvaginal ultrasound model ic5-9d, cracks discovered on probes from multiple va facilities within our visn.Va in popular bluff, mo has received new probes from ge and those devices also have the same defect.Under magnification it is seen pieces of what looks like a seal missing all around the ring.These have been taken out of service at multiple va visn 15 facilities as fluid may be able to enter these cracks and not be effectively cleaned, though covered with sterile sheath during examinations.It states in manufacturer ifu not to use device if cracks are discovered.

• Brand Name: GE IC5-9D
• Type of Device: IC5-9D TRANSVAGINAL US PROBE
• Manufacturer (Section D): GE; wichita KS 67218
• MDR Report Key: 6307551
• MDR Text Key: 66778161
• Report Number: MW5067705
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5194434
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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