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

Model Number 1565160

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician inspected the surgical light system and found that the snap ring was not in its proper place.The spring arm was replaced and the light functioned 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.

Event Description

A customer reported that the spring arm was loose on a trumpf medical surgical light system.An inspection of the device revealed that the snap ring was not in its proper place, allowing the spring arm to slide out of place from its connection point to the center axis.No injuries were reported.

• Brand Name: ILED 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: 8739180
• MDR Text Key: 149548199
• Report Number: 9681407-2019-00017
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1565160
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1