MAUDE Adverse Event Report: MAQUET GMBH OTESUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	116001D0
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Getinge became aware of an issue with one of our table 116001d0 - or table column, manoeuvrable.As it was stated, while using the down function in the reverse trendelenburg position, the column rose several centimeters above the floor before suddenly dropping back down, striking the surgeon¿s foot.The injury sustained required surgical intervention.No other injuries were reported.We have decided to report the issue due to the serious injury sustained by the surgeon.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.D10 concomitant products: 115030d0 - modular universal table top s/n (b)(6).E1 initial reporter: (b)(6).E1 event site name: (b)(6) hospital.

• Brand Name: OTESUS OPERATING TABLE SYSTEM
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: diana gutekunst ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 25374616
• Report Number: 3013876692-2026-00073
• Device Sequence Number: 21197885
• Product Code: FQO
• UDI-Device Identifier: 04046768122161
• UDI-Public: (01)04046768122161(11)221129
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026
• Report Date (Section F): 06/03/2026

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: Health Professional
• Device Model Number: 116001D0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2026
• Device Age: 41 MO
• Date Report to Manufacturer: 06/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 115030D0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 06/03/2026