MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

Model Number 989605455171

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 encountering an articulation issue with their x8-2t model transducer during a tee examination.There was no injury associated with this event.

Manufacturer Narrative

Evaluation of the x8-2t model transducer confirmed the probe had lost its ability articulate in the anterior direction.After tearing down the transducer, a visual inspection revealed the steering cable used to create movement in the bending neck had pulled out of the distal ferrule.The distal ferrule is swaged or crimped onto the steering cable by the vendor, and the investigation concluded this process was performed incorrectly.A supplier change assessment (sca) has been initiated to increase the sample size for a destructive tensile strength test which will validate the ferrule swage and crimp in future manufacturing.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: TRANSDUCER X8-2T
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8485353
• MDR Text Key: 141172970
• Report Number: 3019216-2019-00015
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (y/n): N
• PMA/PMN Number: K163120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605455171
• Device Lot Number: B2JJJK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1