MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7 TRIO / QUAD; SURGICAL LIGHT

Model Number 4068310

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The slc handle was exchanged and returned to trumpf medical for investigation.It was identified that the locking mechanism that holds the handle in place was worn down.As a result, it is possible that the slc handle will come loose without pressing the locking pin.Trumpf medical has replaced the slc handle to resolve the issue.

Event Description

The customer reported that the slc handle fell from a light head during surgery and struck a patient in the back.No injuries were reported.

• Brand Name: ILED 7 TRIO / QUAD
• Type of Device: SURGICAL LIGHT
• 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
• MDR Report Key: 8768411
• MDR Text Key: 202612489
• Report Number: 9681407-2019-00016
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• 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