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

Model Number 4028310

Device Problem Flaked (1246)

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

Event Date 10/11/2021

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.The device involved in this event passed it's expected lifetime of 10 years.An offer will be made to the customer to replace the damaged lights.The surface coating process has been updated to include additional testing and verification.Based on this information, no further action is required.

Event Description

It was reported when the surgeon positioned two iled light heads over the sterile surgical field, the two light heads collided.As a result paint particles fell off of the device and on the patient¿s open abdomen.No injury was reported but a dermal application of a betadine antiseptic solution was provided to the area of surgery.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED CEILING TRIO
• 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: steffen ulbrich ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 13060574
• MDR Text Key: 286754255
• Report Number: 9681407-2021-00038
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995949
• UDI-Public: 887761995949
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

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 Model Number: 4028310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 12/22/2021
• 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