MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUMPF ILED 5; ILED 5 LIGHT SURGICAL CEILING MOUNTED

Model Number ILED 5

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

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.Olympus (b)(4) confirmed that the account signed for the delivery of the notice and returned a confirmation of receipt stating that they were aware of the potential issue (b)(6) 2016.

Event Description

A trumpf iled 5 surgical light and installed by olympus (b)(4) fell from the central axis to the floor at (b)(6) hospital, (b)(6).The incident occured during a surgical procedure.No patient or staff impact occured as a result, and the procedure was not affected.Analysis of the spring arm mounting collar hardware showed the snap ring came dislodged.

• Brand Name: TRUMPF ILED 5
• Type of Device: ILED 5 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: 5864460
• MDR Text Key: 52838990
• Report Number: 9681407-2016-00009
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K06137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ILED 5
• Device Catalogue Number: 4028210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2008
• 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