MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 3; ILED 3 LIGHT, SURGICAL, CEILING MOUNTED

Model Number ILED3

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Issue (2379); Physical Property Issue (3008)

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

Event Date 06/22/2016

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 was sent the initial field safety notice letter on january 14, 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.The letter was confirmed as delivered and signed for by (b)(6) 1/15/2016.No confirmation of receipt (as requested in the initial field safety notice letter) has been returned to trumpf medical at this time.

Event Description

A surgical technician was positioning the lamp head in preparation for the case when the iled 3 spring arm broke free from the upper ceiling mounted central axis arm and the entire assembly fell to the floor.

• Brand Name: ILED 3
• Type of Device: ILED 3 LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; 07318 saalfeld, ; GM
• Manufacturer Contact: karen campbell ; 1046 legrand blvd; charleston, SC 29492 ; 8434161361
• MDR Report Key: 5786817
• MDR Text Key: 50179078
• Report Number: 9681407-2016-00008
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: ILED3
• Device Catalogue Number: 1565160
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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