Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

X8-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number TRANSDUCER X8-2T
Device Problem Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
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 x8-2t model transducer had an articulation issue during use.There was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of the transducer could not confirm the articulation issue as described by the customer.However, investigation of the device revealed the connector had corrosion and was chipped, a dented rack actuator, a worn i-tube, and deep bite marks on the window and tip shell.The transducer articulation mechanism was fully functional and met all articulation angle specifications.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
X8-2T
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
MDR Report Key11322785
MDR Text Key231649434
Report Number3019216-2021-10006
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00884838069718
UDI-Public00884838069718
Combination Product (y/n)N
PMA/PMN Number
K163120
Number of Events Reported1
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
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTRANSDUCER X8-2T
Device Catalogue Number989605455171
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-