MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED DUO; ILED3 SURGICAL LIGHT

Model Number 1565160

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to the facility and found a gap between the spring arm and central axis.The technician found that the snap ring and washer that hold the spring arm were in the central axis cavity, but out of their proper position.The spring arm was put back into place and secured properly with a new snap ring and washer.A review of the product's service history indicates that an inspection was performed on (b)(6) 2017 as a part of the open fda correction #z-563-2016 and the snap ring was noted to have been seated correctly.On (b)(6) 2017, the central axis was replaced due to video signal issues.This activity requires the removal and replacement of the spring arms, and it is believed that the snap rings were incorrectly installed during this process.

Event Description

A spring arm with an attached flat panel bracket began to separate from the central axis of a trumpf medical surgical light.The spring arm did not fully separate from the axis, but a gap was observed between the two components.No patient or caregiver impact reported.

• Brand Name: ILED DUO
• Type of Device: ILED3 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: 6756712
• MDR Text Key: 81727879
• Report Number: 9681407-2017-00025
• 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,user faci
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1565160
• Device Catalogue Number: I131-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-563-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Death