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

Model Number 4068210

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

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system due to the spring arm falling out of the socket.The technician reconnected the spring arm to the central axis and reseated the circlip.The root cause of this malfunction was determined to be improper installation of the device.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.The root cause of this malfunction was determined to be the same issue identified in the recall.

Event Description

The customer reported that the spring arm of a trumpf medical surgical light was falling out of the socket.No injury was reported.

• Brand Name: ILED 7 DUO
• 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: 9119250
• MDR Text Key: 203155473
• Report Number: 9681407-2019-00031
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4068210
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2018
• 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