MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER

Model Number	989605431171
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 s8-3t model transducer was producing poor image quality.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer confirmed the imaging issue as described by the customer.Investigation of the device noted oil separation in the lens, a hole in the sheath, and bite marks to the scope causing fluid ingress damage.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.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: S8-3T MICRO TEE TRANSDUCER
• Common Device Name: S8-3T MICRO TEE TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9438947
• Report Number: 3019216-2019-00086
• Device Sequence Number: 10857655
• Product Code: ITX
• UDI-Device Identifier: 00884838073524
• UDI-Public: (01)00884838073524
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K030455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 989605431171
• Device Lot Number: B2HWZC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/09/2019
• 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