MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT; LIGHT SURGICAL, CEILING MOUNTED

Model Number 1574850

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

A field corrective action has been initiated by trumpf medical and reported to the fda as a result of investigations into similar events.The investigations have found that improper installation or servicing of the snap ring in this joint can result in the slipping down or falling of the spring arm and light head components.The user facility had confirmed receipt of the initial field safety notice letter on february 18, 2016, which informs users of the risk and advises that visual inspections be completed prior to each use.The field action activities including inspection and additional labeling are ongoing.

Event Description

During the setup of a room a rn preparing, the room moved the surgical light.The surgical light and spring arm fell to the floor.No one was injured.The snap ring that secures the joint had become dislodged.

• Brand Name: TRULIGHT
• Type of Device: LIGHT SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; 07318; saalfeld, saale ; GM
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; 07318; saalfeld, saale ; GM ; 6715864140
• MDR Report Key: 5590600
• MDR Text Key: 43167346
• Report Number: 9681407-2016-00003
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/21/2016

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 Operator: Health Professional
• Device Model Number: 1574850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-563-2016
• Patient Sequence Number: 1