MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 989605350452

Device Problem Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported an articulation issue with their x7-2t model transducer.There was no injury associated with this event.

Manufacturer Narrative

A thorough evaluation of the x7-2t model transducer identified damage to the device.Visual inspection of this probe revealed wear to the cable, i-tube, and window.Further performance testing found the steering cable ferrule had insufficient solder resulting in the failure to articulate in the anterior direction.An evaluation for potential design change improvements are currently underway.

• Brand Name: X7-2T TRANSDUCER (MTEE)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8061143
• MDR Text Key: 127074859
• Report Number: 3019216-2018-00052
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838075177
• UDI-Public: (01)00884838075177
• Combination Product (y/n): N
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605350452
• Device Lot Number: B1Z2H3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1