MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5520; SURGICAL LIGHT

Model Number 4075520

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

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician evaluated the light system and found paint chipping on the light head.The light head was replaced and the device is functioning as designed.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.

Event Description

During an inspection of the light system, chipping paint was found on the light head.No injury was reported.

• Brand Name: TRULIGHT 5520
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9119248
• MDR Text Key: 195269135
• Report Number: 9681407-2019-00032
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4075520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• 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