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

Model Number	116001C0
Medical Device Problem Code	Unintended Movement (3026)
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.
Event or Problem Description
Getinge became aware of an issue with one of our columns - 116001c0 - otesus or table column, mobile.As it was stated, the table moved up in the middle of the case with no interaction.According to provided information, the patient was being assessed following the incident.Further details regarding the incident have been requested, however, to date no further information have been received.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during procedure, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns - 116001c0 - otesus or table column, mobile.As it was stated the table moved unintentionally upward during a gynecological surgery while the patient was under anesthesia.According to the provided details the patient was secured with belts, so the unintended movement did not alter the patient¿s position or delay the procedure, which continued as planned.After the incident, the patient¿s condition was evaluated, and no injuries were reported.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during procedure, was to reoccur.A technical inspection of the affected device was conducted, and no malfunction was found.The investigation confirmed that no external factors, such as footswitches, tegris systems, or remote controls, contributed to the incident.Additionally, a review of the table¿s logs revealed no errors.The failure was non-reproducible and did not recur since the reported event.Following recalibration and functional testing, the device was cleared for use and returned to service.Based on the investigation conducted, it was concluded that at the time of the event, the device was actively being used for the patient¿s treatment and was therefore directly involved in the reported incident.Since the operating table malfunction was not found, it was determined that the getinge device did not fail to perform according to its specified functions.A review of received customer product complaints found no past reports of similar incidents resulting in injury to either a patient or an operator.In summary and as a result of the root cause evaluation, it can be concluded that the root cause of the reported issue, namely the unintended movement of the table during procedure, as well as the malfunction of the getinge device, could not be confirmed.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.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation and the additional information that has been received.Previous b5 describe event or problem: getinge became aware of an issue with one of our columns - 116001c0 - otesus or table column, mobile.As it was stated, the table moved up in the middle of the case with no interaction.According to provided information, the patient was being assessed following the incident.Further details regarding the incident have been requested, however, to date no further information have been received.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during procedure, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our columns - 116001c0 - otesus or table column, mobile.As it was stated the table moved unintentionally upward during a gynecological surgery while the patient was under anesthesia.According to the provided details the patient was secured with belts, so the unintended movement did not alter the patient¿s position or delay the procedure, which continued as planned.After the incident, the patient¿s condition was evaluated, and no injuries were reported.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during procedure, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our columns - 116001c0 - otesus or table column, mobile.As it was stated the table moved unintentionally upward during a gynecological surgery while the patient was under anesthesia.According to the provided details the patient was secured with belts, so the unintended movement did not alter the patient¿s position or delay the procedure, which continued as planned.After the incident, the patient¿s condition was evaluated, and no injuries were reported.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table during 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: 20794902
• Report Number: 8010652-2024-0000095
• Device Sequence Number: 12470671
• Product Code: FQO
• UDI-Device Identifier: 04046768100671
• UDI-Public: (01)04046768100671(11)201112
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 11/27/2024

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: 116001C0
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown