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

Model Number 1574851

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Output Problem (3005); Radiation Overexposure (3017); Radiation Output Problem (4026)

Patient Problem Skin Discoloration (2074)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The light heads of the suspect device have been removed from use and will be returned to trumpf medical for evaluation and investigation.The investigation is currently ongoing.Trumpf medical is unable to confirm at this time if the light heads malfunctioned in a way that would potentially cause or contribute to a serious injury.This report is being filed in an abundance of caution until the investigation is complete.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 discoloration was found on the patient's abdomen.This is not a serious injury per the fda medical device reporting regulations.

Manufacturer Narrative

The light heads returned were investigated by hillrom.No malfunction was identified which is likely to cause the skin tanning.The devices are within the specification for maximum illuminance values to not cause skin tanning.The root cause could not be identified clearly but was most likely caused by overlapping of more than one light filed which is clearly forbidden by the instructions for use.Based on this no further actions are necessary.

• Brand Name: TRULIGHT TRIBLE TUSM
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9810791
• MDR Text Key: 196131369
• Report Number: 9681407-2020-00014
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1574851
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 17