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

Model Number	ENSITE-FF-ABRKT-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a clinical specialist that while preparing the cath lab for an ep procedure that a workplace injury was sustained.While attaching the magnet onto the table, the bracket for the magnet stuck and when trying to attach it, the individual used their thumb to pry on the table and their thumb cracked and bent back.An orthopedic surgeon was consulted.An mri showed a partial tear in the ligament.A brace was recommended and a follow up is planned for the end of (b)(6).
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: ENSITE¿ X FIELD FRAME BRACKET
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24533563
• Report Number: 2184149-2026-00058
• Device Sequence Number: 18376156
• Product Code: DQK
• UDI-Device Identifier: 05415067033550
• UDI-Public: 05415067033550
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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): 04/07/2026

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-ABRKT-01
• Device Catalogue Number: ENSITE-FF-ABRKT-01
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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