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

Model Number	116001A0
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 initial reporter: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our columns - 116001a0 - otesus or table column, stationary.As it was stated, the column was no longer responding and could not be operated with the wired remote control or the override panel during pelviscopy.The issue resulted in a delay and prolonged anesthesia time for the patient.During a service visit on site, a hinged cover was found to be missing, which could allow fluid to penetrate and cause problems.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 the remote control or override panel, leading to inability to position the table as required during the procedure, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns - 116001a0 - otesus or table column, stationary.As it was stated, the column was no longer responding and could not be operated with the wired remote control or the override panel during pelviscopy.The issue resulted in a delay and prolonged anesthesia time for the patient.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 the remote control or override panel, leading to inability to position the table as required during the procedure, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As the malfunction occurred, it was considered that the getinge device failed to meet its specifications.A review of the received customer product complaints revealed that there were no serious injuries to a user nor to a patient or operator when this particular issue occurred.The affected device was evaluated by a getinge technician.A hinged cover was found to be missing, which could allow fluid to penetrate and cause problems.The cover was fitted and the device was released for use.Based on the information provided by the technician, it is possible that the hinged cover came off due to the collision.In the instructions for use, the user is advised to remove potential hindrances before moving / adjusting the the device and avoid collisions (ifu 1160.01 en 13, page 32).The user is also instructed that it is necessary to have visual and functional inspections performed by a trained person prior to each use to ensure correct operation (ifu 1160.01 en 13, page 108).Faulty or defective products may result in injuries.The user shall stop using faulty or defective products and inform the getinge representative (ifu 1160.01 en 13, page 30).The user continued using the defective product, which consequently resulted in repeated incidents during procedures on the patients.In summary, as a result of the performed evaluation, it can be concluded that the root cause of the reported issue, the operating table not responding to the remote control or override panel, leading to inability to position the table as required during the procedure, is related to user error.We currently do not have any information that would warrant further action regarding device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.Initial reporter: on-site medical technician.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: getinge became aware of an issue with one of our columns - 116001a0 - otesus or table column, stationary.As it was stated, the column was no longer responding and could not be operated with the wired remote control or the override panel during pelviscopy.The issue resulted in a delay and prolonged anesthesia time for the patient.During a service visit on site, a hinged cover was found to be missing, which could allow fluid to penetrate and cause problems.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 the remote control or override panel, leading to inability to position the table as required during the procedure, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our columns - 116001a0 - otesus or table column, stationary.As it was stated, the column was no longer responding and could not be operated with the wired remote control or the override panel during pelviscopy.The issue resulted in a delay and prolonged anesthesia time for the patient.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 the remote control or override panel, leading to inability to position the table as required during the procedure, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our columns - 116001a0 - otesus or table column, stationary.As it was stated, the column was no longer responding and could not be operated with the wired remote control or the override panel during pelviscopy.The issue resulted in a delay and prolonged anesthesia time for the patient.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 the remote control or override panel, leading to inability to position the table as required during the procedure, 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: 21974064
• Report Number: 8010652-2025-0000016
• Device Sequence Number: 7227731
• Product Code: FQO
• UDI-Device Identifier: 04046768100657
• UDI-Public: (01)04046768100657(11)220913
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 116001A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown