MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X FIELD FRAME; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-FF-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while preparing the cath lab for an ep procedure that a workplace injury was sustained.While setting up the ensite x system, it was noted that the prs-p and prs-a were not in proper position.While adjusting the field frame and mounting bracket, a pull was felt along the upper and lower back.The pain worsened throughout the procedure and resulted in an urgent care visit.

• Brand Name: ENSITE¿ X FIELD FRAME
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24641046
• Report Number: 2184149-2026-00075
• Device Sequence Number: 9797115
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: ENSITE-FF-01
• Device Catalogue Number: ENSITE-FF-01
• Device Lot Number: 10069416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown