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

Model Number 1574850

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

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician inspected the surgical light system and found that the circlip was off the spring arm mount causing the spring arm to drop a few inches.The circlip 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 alleged the trumpf monitor arm "c" bracket came loose causing monitor to drop down from support arm a few inches.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT DUO 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: 10447494
• MDR Text Key: 205019079
• Report Number: 9681407-2020-00051
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1574850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• 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