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

Model Number 4028310

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The sterile handle adapter was replaced at the facility.The investigation is currently ongoing and a follow-up report will be submitted once more information is available.

Event Description

A sterile handle adapter on an iled 3 lamphead failed to secure the handle, which fell during a surgery and struck a patient.No injury was reported.

Manufacturer Narrative

The light handle adapter was returned to trumpf medical for further investigation.All dimensions were found to be correct, per product specification.No abnormalities were detected.The part was tested on an iled at the trumpf medical facility and functioned as intended.The adapter could not be loosened or removed without pressing the locking ball.The root cause of the incident is likely that the adapter was not locked correctly by the user at the time the event occurred.

• Brand Name: ILED
• 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 ; 6715864140
• MDR Report Key: 6504709
• MDR Text Key: 73456997
• Report Number: 9681407-2017-00014
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4028310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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