MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG KOPFPLATTE DOPPELGELENK H V; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1850955
Medical Device Problem Codes	Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Within a first investigation based on provided pictures a defect gas spring was noticed.The device will be investigated to determine the root cause.Results will be provided within a follow-up report.
Event or Problem Description
The customer reported that during a surgical procedure the head of the patient dropped unexpected due to a defect head section of the operating table.No injury was reported in relation to this event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During device investigation it was identified that a gas spring, which is responsible for adjustment and holding the position of the head section, was broken.Because of this break the reported dropping of the head section was possible.The root cause for the break of the plunger rod of the gas spring was caused by an excessive force which cannot occur during the intended use of the device.This force must have occurred by a massive overload or mishandling of the head section.A solely device malfunction could not be confirmed as a result of the investigation.A use error is most likely root cause for the event.The defect gas spring was exchanged by the customer.Based on the investigation results, risk assessment and the event evaluation no further actions are necessary.
Event or Problem Description
The customer reported that during a surgical procedure the head of the patient dropped unexpected due to a defect head section of the operating table.No injury was reported in relation to this event.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: KOPFPLATTE DOPPELGELENK H V
• 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: 12201894
• Report Number: 3007143268-2021-00011
• Device Sequence Number: 19163431
• Product Code: GDC
• UDI-Device Identifier: 00887761991354
• UDI-Public: 887761991354
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 09/27/2021

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: No Information
• Device Model Number: 1850955
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1