MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1604788
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During device inspection no defect or malfunction was identified.The device was working as intended.Additionally, the log files of the device were reviewed.At the time of the event the device provided warnings to the user based on a detected potential collision and a horizontal misalignment of the or-table base.The event was most likely caused by a collision with a foreign equipment during the movement in reverse trendelenburg position.During this collision the or-table base may lifted from the floor and later the device slipped from the foreign equipment causing a drop.The event could not be traced to a device malfunction or failure.According to the user manual the operator of the device needs to observe all movements performed to ensure no collision will occur.Based on the information available at the time of this evaluation, the reported injury cannot solely be contributed to the device, as the device would not come in direct contact with the patient¿s internal organs causing internal injury.It is likely that the reported injury is due to improper use/technique by the user.In a surgical environment, a steady surgical field/surgical site is imperative.During the intentional movement of the surgical table/patient (i.E.Trendelenburg or reverse trendelenburg), it is best practice to remove surgical instruments from the surgical cavity to prevent accidental injury to the patient and ensure no accessory equipment is in close proximity to the surgical table that could potentially cause a collision and unintentional movement.Based on this no further action is required.
Event or Problem Description
The customer alleged the operating table trusystem 7000 jumped and turned during a surgical procedure.The device was put into reverse trendelenburg position when this happened.As a result it was reported the patient sustained an injury (puncture) to the liver.The reported injury was corrected at the time of the event and the patient went home the same day.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 12056885
• Report Number: 3007143268-2021-00009
• Device Sequence Number: 3348521
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: No Information
• Device Model Number: 1604788
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention