MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG PST 500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4080100
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the first device inspection one part of the parking brake did release allowing the device to tilt (wobble).The investigation of the root cause is currently ongoing and will be provided within a final report if new information becomes available.
Event or Problem Description
It was reported, during a very precise surgical procedure the operating table became unstable (tilting).No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
According to the on-site device inspection one part of the parking brake did release allowing the device to tilt (wobble).The hydraulic unit, which is responsible for the brake system was exchanged and returned for further investigations.The supplier of the hydraulic unit was able to reproduce the described failure.As the root cause it was identified that air was introduced in the hydraulic system during the testing procedure of the assembly.This additional air caused the brake system to not work correctly and the operating table to tilt (wobble) during the procedure.The hydraulic unit, which is responsible for the brake system, was replaced.The supplier changed the testing procedure to release introduced air and to minimize the introduction of additional air into the hydraulic system.Based on this information, no further action is required.
Event or Problem Description
It was reported, during a very precise surgical procedure the operating table became unstable (tilting).No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PST 500
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss-strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 12048378
• Report Number: 3007143268-2021-00008
• Device Sequence Number: 19731021
• Product Code: GDC
• UDI-Device Identifier: 00887761979390
• UDI-Public: 887761979390
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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
• Device Model Number: 4080100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown