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U.S. Department of Health and Human Services

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

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PHILIPS ULTRASOUND, INC TRANSDUCER S7-3T 21781A TEE PROBE ASSEMBLY Back to Search Results
Model Number 989605406772
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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.
 
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 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.
 
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Brand NameTRANSDUCER S7-3T
Type of Device21781A TEE PROBE ASSEMBLY
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key6765648
MDR Text Key261533037
Report Number3019216-2017-00027
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605406772
Device Lot NumberB1CM64
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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