MAUDE Adverse Event Report: STIILLE AB IMAGIQ3 LEGACY; TABLE, OPERATING ROOM, ELECTRIC

Model Number	550-1700
Medical Device Problem Codes	Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was prepared by jane campbell, us agent and official correspondent for stille ab.Company name: (b)(6).Address: (b)(6).Telephone number: (b)(6).E-mail: (b)(6).Secure email: (b)(6).
Event or Problem Description
B5: description of event: during or at end of a procedure, (b)(6) 2025, the standard trendelenburg movement of the table stopped working unexpectedly due to a loosened internal screw.Please note that the reverse trendelenburg and emergency trendelenburg functions remained fully operational.Although no patient harm occurred, we believe this malfunction could potentially lead to a serious injury if it were to occur during a critical surgical procedure.More closely, the end user did not know that the malfunction depended on the loosen screw, but we understood it when stille's service engineer came on site 17 june.

• Brand Name: IMAGIQ3 LEGACY
• Common Device Name: TABLE, OPERATING ROOM, ELECTRIC
• Manufacturer (Section D): STIILLE AB; ekbacken 11; torshalla, SE-64 4 30; SW SE-644 30
• Manufacturer (Section G): STILLE AB; ekbacken 11; torshalla SE-64 4 30; SW SE-644 30
• Manufacturer Contact: katalin daroczy ; ekbacken 11; torshalla, SE-64-4 30 ; SW SE-644 30
• MDR Report Key: 22888431
• Report Number: 3003696170-2025-00001
• Device Sequence Number: 4939787
• Product Code: GDC
• UDI-Device Identifier: 07332339238179
• UDI-Public: 07332339238179
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Notification,Repair,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 550-1700
• Device Catalogue Number: 550-1700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003696170-2025-00001C
• Patient Sequence Number: 1
• Patient Sex: Unknown