MAUDE Adverse Event Report: S7-3T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	TRANSDUCER S7-3T
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2020
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 s7-3t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer confirmed the imaging issue was rotational and not an articulation failure.The transducer failed parallel resistance and image rotation performance tests.Investigation of the device revealed dried fluid ingress and corrosion in the cable, a dent in the cable jacket, and scratches to the beading, window, and tipshell.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• Brand Name: S7-3T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10984036
• Report Number: 3019216-2020-00117
• Device Sequence Number: 17208116
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: 00884838061439
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132304
• 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

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: TRANSDUCER S7-3T
• Device Catalogue Number: 989605406772
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/19/2021
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 04/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1