MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT DUO TUSM; SURGICAL LIGHT

Model Number 1574850

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

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

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that paint chipping fell from the light into the sterile field.The investigation of this allegation is still ongoing, and will be updated once a final resolution has been reached.

Event Description

The customer reported that paint chipping fell from the light into the sterile field.No injury reported.

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system due to paint chipping and falling from the light into sterile field.Trumpf medical offered to repair the affected parts of the light for the customer.The customer has not accepted or declined the offer to repair the parts.The investigation identified steps in the preparation for coating process which can lead to lack of paint adhesion resulting in paint chipping.Additionally, collisions of the light heads and use of unapproved cleaners can further contribute to paint chipping from the light system.The damage to the painted surfaces usually does not develop suddenly but develops over time.The instructions for use state that the devices must be checked for proper condition prior to each use.Damaged devices must not be used.If damage to the surface coating is recognized and removed, there is no danger to the patient.The surface coating process has been updated to include additional testing and verification.Based on this information, no further action is required.

• Brand Name: TRULIGHT DUO TUSM
• 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: 9295194
• MDR Text Key: 166817074
• Report Number: 9681407-2019-00046
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1574850
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1