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

Model Number 4038120

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

Trumpf medical was made aware by the spring arm supplier that 12 spring arms sold to trumpf medical may have an out of specification weld.This device was under a field corrective action at the time of the failure.The spring arm involved in this event was impacted by that field action and had not yet been replaced.The devices included in this field action were not sold in the united states.

Event Description

The joint of the spring arm component of the mobile surgical light failed.The spring arm and light head became detached from the stand and fell during a surgical case.No injuries were reported.

• Brand Name: TRULIGHT
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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 ; 9367158641
• MDR Report Key: 5217443
• MDR Text Key: 30981916
• Report Number: 9681407-2015-00013
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K091246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Hospital Service Technician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4038120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2012
• 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