MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7 TRIO; SURGICAL LIGHT

Model Number 4068310

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Injury (2348); Superficial (First Degree) Burn (2685)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The light heads of the suspect device will be returned to trumpf medical for evaluation and investigation.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer alleged that post-surgery burn marks were found on the patient's body on the area that the iled 7 light field was positioned.The patient received a minor skin burn.

• Brand Name: ILED 7 TRIO
• 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: 9738555
• MDR Text Key: 199987903
• Report Number: 9681407-2020-00010
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO