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

Model Number 1574851

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician inspected the surgical light system and found the snap ring undone.The snap ring was replaced and the light is functioning as designed.A field corrective action has been initiated by trumpf medical and reported to the fda as a result of investigations into similar events (recall number z-563-2016).The investigations have found that improper installation or servicing of the circlip in this joint can result in the slipping down or falling of the spring arm and light head components.Based on this information, no further action is required.

Event Description

The customer reported that the snap ring came undone.No injury reported.

• Brand Name: TRULIGHT TRIO 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, 07318 ; GM 07318
• MDR Report Key: 9516217
• MDR Text Key: 202205912
• Report Number: 9681407-2019-00059
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1