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

Model Number ILED 3 DUO

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

Patient Problems Pain (1994); Sprain (2083)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

A trumpf iled 3 surgical light installed by a (b)(4) distributor fell from the central axis.A field corrective action has been initiated by trumpf medical and reported to the fda as a result of investigations into similar events.(recall number z-563-2016).The field action inspection was completed in july 2016 by the (b)(4) distributor.The light system was later reconfigured, at the request of the customer, by the (b)(4) distributor in august of 2017.Analysis of the central axis and spring arm mounting collar hardware showed the snap ring became dislodged after the system was reconfigured by the (b)(4) distributor.The investigations 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.(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 2/5/2016.

Event Description

Surgical staff was positioning the lamp head and the arm fell from the central axis.The staff member was able to control the lamp head, so that it did not contact the patient or other staff.As a result, the staff member suffered a sprained ligament in the shoulder and reported back and shoulder pain.

• Brand Name: TRULIGHT
• 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: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 7082697
• MDR Text Key: 93753198
• Report Number: 9681407-2017-00040
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: ILED 3 DUO
• Device Catalogue Number: 1565160
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other