MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; TS7000

Model Number TRUSYSTEM 7000 U (DV)

Device Problems Disconnection (1171); Device Issue (2379); Connection Problem (2900); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Use error during the table set up and patient prep may have contributed to the incorrect installation of the double-jointed head section per operating room staff interviewed.The double jointed head section involved in the incident has not been returned to trumpf medical for investigation.Trumpf medical is currently working with the customer's risk management department for the release of the component.If new relevant information becomes available following the evaluation of the head section, a follow up report will be submitted.

Event Description

A double jointed head section accessory, on a trusystem 7000dv surgical table, dropped to the floor during a case with a patient on the table.The head section only supports the patient's head.The patient's upper back and shoulders are supported independent of this attachment.The head section was reinstalled on the table and the patient was reconfigured.No injuries were reported.

• Brand Name: TRUSYSTEM
• Type of Device: TS7000
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318 ; 6715864140
• MDR Report Key: 6656687
• MDR Text Key: 78253556
• Report Number: 3007143268-2017-00015
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: TRUSYSTEM 7000 U (DV)
• Device Catalogue Number: 1723633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1