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

Model Number TRANSDUCER X7-2

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

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 Description

A customer reported an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.

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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11066152
• MDR Text Key: 225778825
• Report Number: 3019216-2020-00126
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: 00884838061668
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1