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

Model Number 12282

Device Problems Flaked (1246); Material Separation (1562)

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The defective device will be returned to trumpf medical for examination.The investigation is currently in-process.A follow-up report will be submitted once the investigation evaluation is complete.

Event Description

A powder coat paint chip detached from the surgical light lamp head and fell into the operating field.No injury was reported.

Manufacturer Narrative

The affected device was replaced at the facility.The returned, defective parts were investigated and evaluated.Our investigation has identified steps in the manufacturing process which combined with non-approved cleaners can lead to the paint chipping.The damage to the painted surfaces usually does not develop suddenly, but develops over time.The instructions for use state that the devices must be checked for proper condition prior to each use.Damaged devices must not be used.If damage to the surface coating is recognized and removed, there is no danger to the patient.The surface coating process will be updated to include additional testing and verification.

• Brand Name: ILED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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, saale 07318 ; GM 07318 ; 6715864140
• MDR Report Key: 6190813
• MDR Text Key: 63312965
• Report Number: 9681407-2016-00017
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12282
• Device Catalogue Number: 4028310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2010
• 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