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

Model Number	989605455171
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
A customer reported an x8-2t model transducer had a partial loss of articulation during use.The procedure in progress was completed successfully with no negative patient outcome.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the x8-2t model transducer confirmed the probe had lost its ability to articulate.A thorough functional and 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
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10017640
• Report Number: 3019216-2020-00025
• Device Sequence Number: 2502644
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K163120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 989605455171
• Device Lot Number: B3J4LK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1