MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT; TRULIGHT MOBILE

Model Number TRULIGHT

Device Problems Component Falling (1105); Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected by a local service technician and the device was not returned to trumpf medical.It was discovered that the caster brakes at the base of the mobile light were engaged at the time of the incident and cause the light to fall when the user attempted to move the light.If new relevant information becomes available, a follow-up report will be submitted.

Event Description

The arm of the mobile light tilted down causing the light head to fall onto the patient.The light head struck the patient on the right ankle breaking the sterile field.No medical treatment was required as a result of the incident.

• Brand Name: TRULIGHT
• Type of Device: TRULIGHT MOBILE
• 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: 6190867
• MDR Text Key: 63312535
• Report Number: 9681407-2016-00015
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRULIGHT
• Device Catalogue Number: 4038120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• 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