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

Model Number 4028310

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Hillrom has recommended to the customer to stop using the device until the issue is resolved.An offer will be made to the customer to replace the damaged 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.Based on this information, no further action is required.

Event Description

The customer alleged that during the daily use of the device 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: ILED TRIO
• 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: 11378009
• MDR Text Key: 244192997
• Report Number: 9681407-2021-00009
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995949
• UDI-Public: 887761995949
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4028310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2012
• 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