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

Model Number 1565160

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

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system due to the paint peeling off the arm bracket.During the inspection the technician determined the paint peeling off the arm bracket was due to the light colliding and normal wear from use of the light.The damaged arm bracket was replaced, and the device is functioning as designed.Our investigation has identified steps in the manufacturing process which can lead to the paint chipping.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

A customer reported that the paint on the arm bracket was peeling off.No injury was reported.

• Brand Name: ILED 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
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, gm
• MDR Report Key: 8873891
• MDR Text Key: 202971101
• Report Number: 9681407-2019-00020
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1565160
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2011
• 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