MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5000 / 3000 TRIO / QUAD; SURGICAL LIGHT

Model Number 4038310

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Head Injury (1879)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

During inspection, the technician cited the root cause to be a collision.He reattached the elbow cover and the device is functioning as designed.

Event Description

The spring arm's elbow cover fell during a procedure.The plastic cover struck the patient in the back of the head.No patient or caregiver injury was reported.

• Brand Name: TRULIGHT 5000 / 3000 TRIO / QUAD
• Type of Device: SURGICAL LIGHT
• 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
• MDR Report Key: 8046512
• MDR Text Key: 127566934
• Report Number: 9681407-2018-00066
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4038310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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