MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 1000 / CEILING; SURGICAL LIGHT

Model Number 4058110

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system, however, a technician has been unable to access the device for further investigation and possible device return.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer alleged, the light head dislodged from the spring arm and fell down on the floor.No injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

The customer alleged, the light head dislodged from the spring arm and fell down on the floor.No injury reported.This report was filed in our complaint handling system as complaint #: (b)(4).

Manufacturer Narrative

The examination light was evaluated by a hillrom technician.It was identified a metal plate was broken which caused the light head to detach.Upon further engineering investigation it was concluded, the metal plate broke due to an overload (e.G.Collision, mishandling).A material of design defect was not identified.The device was repaired by a hillrom technician and is functioning as designed.Based on the investigation results no further actions are necessary.

• Brand Name: TRULIGHT 1000 / CEILING
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld 07318 ; GM 07318
• MDR Report Key: 10256961
• MDR Text Key: 202203993
• Report Number: 9681407-2020-00044
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761986084
• UDI-Public: 887761986084
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4058110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1