MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER S7-3T; 21781A TEE PROBE ASSEMBLY

Model Number	989605406772
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that while performing a procedure with an s7-3t model transducer, a portion of the probe¿s tip cracked and began to detach from the device.The transducer was promptly removed from the patient¿s throat with no part of the probe remaining in the patient.The site¿s philips field service engineer confirmed there were no injuries associated with this event.The suspect transducer has been removed from service and will be returned for evaluation.
Additional Manufacturer Narrative
A thorough evaluation of the s7-3t model transducer identified extensive damage to the device.Examination of the transducer noted a missing sheath, a bite mark, a worn and peeling shaft, deep scratches, a dirty handle, dried fluid in the connector, chipped connector housing paint, a discolored connector strain relief, and a damaged control handle.Performance testing revealed a failed icon check and a loss of steering from the top knob.Further evaluation revealed the detached sheath had been exposed to a disinfectant only approved for use on the connector and cable.Inappropriate cleansing or disinfection of this device would have contributed to the material failure and are indicative of improper handling and maintenance.

• Brand Name: TRANSDUCER S7-3T
• Common Device Name: 21781A TEE PROBE ASSEMBLY
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 6765648
• Report Number: 3019216-2017-00027
• Device Sequence Number: 1760301
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: (01)00884838061439
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 989605406772
• Device Lot Number: B1CM64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1