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

Model Number	116001D0
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 occupation: service engineer.
Event or Problem Description
Getinge became aware of an issue with one of our table 116001d0 - or table column, manoeuvrable.As it was stated, during plastic surgery breast operation an attempt was made to change the patient's surgical position using the remote control, however, the table did not move.The surgical position could not be changed to an optimal one.Due to the surgeons poor working position, the suture and ischemia time was prolonged.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to remote control or override panel leading to inability to position the patient, was to reoccur.

• 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: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 24255478
• Report Number: 8010652-2026-0000005
• Device Sequence Number: 8233894
• Product Code: FQO
• UDI-Device Identifier: 04046768122161
• UDI-Public: (01)04046768122161(11)230207
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 116001D0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown