MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5500 PL; SURGICAL LIGHT

Model Number 1537325

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2022

Event Type  malfunction  

Event Description

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

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.The surface coating process has been updated to include additional testing and verification.Comfort yoke was replaced.Functioning as designed.Based on this information, no further action is required.

• Brand Name: TRULIGHT 5500 PL
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15417738
• MDR Text Key: 305288104
• Report Number: 9681407-2022-00014
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1537325
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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