MAUDE Adverse Event Report: X7-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	TRANSDUCER X7-2
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
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 x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
A thorough evaluation of the suspect transducer could not reproduce the articulation issue as described by the customer.The transducer passed all performance testing, however, some cosmetic damage was identified.The investigation of the device revealed bite damage and scratches to the beading, window, and tipshell of the transducer.The physical damage to the transducer is indicative of improper maintenance.Although there was evidence of cosmetic damage, the investigation confirmed the transducer was operating as designed with no malfunctions.

• Brand Name: X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11066152
• Report Number: 3019216-2020-00126
• Device Sequence Number: 11089538
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: 00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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 X7-2
• Device Catalogue Number: 989605414122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Distributor Facility Aware Date: 12/11/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• 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