MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 5, SINGLE, CEILING MOUNTED; OPERATING LIGHT SYSTEM

Model Number 1357779

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system due to the iled spring arm joint cover falling into the sterile field during a surgical procedure.During the inspection, it was found that the spring arm joint cover detached and fell due to a collision of a light head with the spring arm/cover.The spring arm cover was replaced, and the device is functioning as designed.It is known that improper installation, maintenance, or collision can lead to the spring arm covers falling off.Based on this information, no further action is required.

Event Description

I led spring arm joint cover fell into the sterile field during surgical procedure.No injury reported.

• Brand Name: ILED 5, SINGLE, CEILING MOUNTED
• Type of Device: OPERATING LIGHT SYSTEM
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: florian denk ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9328075
• MDR Text Key: 179525755
• Report Number: 9681407-2019-00051
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1357779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1