MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5300; SURGICAL LIGHT

Model Number 1790103

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

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

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.An offer will be made to the customer to replace the damaged parts.The surface coating process has been updated to include additional testing and verification.Based on this information, no further action is required.

Event Description

Trumpf medical received a report from the customer stating that paint particles are chipping from the light head.No injuries were reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 5300
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl-zeiss-strasse; saalfeld 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; 7-9 carl-zeiss-strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 11235694
• MDR Text Key: 230027885
• Report Number: 9681407-2021-00001
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1790103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1