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

Model Number 4028310

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Issue (2379)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical sales rep found that it was possible to release the handle adapter without pressing the unlocking pin.The locking pin was adjusted and the handle adapter worked properly.The lamp head was replaced by trumpf service and returned for further analysis.A follow-up report will be submitted if new information becomes available.

Event Description

The sterile handle & adapter fell off lamp head.No injury occurred.

Manufacturer Narrative

A trumpf medical technician exchanged the lamp head's handle and handle adapter.The new parts were found to be operating as intended post repair.Affected parts of this event were investigated and the failure mode was replicable.The investigation was completed as a part of a capa for this failure mode.Areas of investigation included: insufficient design requirements for those functional parts and validation procedures to ensure a correct design - product development process has been updated in june 2016.Design (tolerances, combination of the detent as operating function and holding function) - as part of a design change, the tolerances were adjusted at one part of the locking system.This change was implemented on december 01, 2015.This design is not used within other operating lights.Deviations in production and assembly - process stability for each step, missing parts to secure the locking pin will operate as intended (at one investigated part a screw was missing).Use error (adapter not correctly attached or locked or damaged handle adapter used) - by a specific operation (pull and push at specific angles) it was possible to release the adapter without pressing the locking pin.All preventative maintenance is performed with the help of a maintenance log or check list which verifies that the device is properly locked, easily removable and attachable.It remains unclear in which interaction the aforementioned causes must occur to trigger the release of the handle.However, the handle cannot fall independently by its own weight if it is correctly locked.The medical devices affected by this failure mode have not been produced since the end of 2017.Based on this information, no further action is required.

• Brand Name: ILED TRIO
• 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: 7517758
• MDR Text Key: 108614073
• Report Number: 9681407-2018-00024
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4028310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1