MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION MICRO-CONVEX; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number IC5-9-D

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

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

Event Date 09/05/2019

Event Type  malfunction  

Event Description

Repeated failures of certain endocavity ultrasound probes; the cap at the end of the probe may become dislodged and result in oil leakage.

• Brand Name: MICRO-CONVEX
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE HEALTHCARE JAPAN CORPORATION; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 9145980
• MDR Text Key: 160906580
• Report Number: 9145980
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IC5-9-D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1