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 Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician was dispatched to evaluate the light system.During the inspection, no problems were found with the device.The technician could not duplicate the reported problem.He replaced the sterilizable handle.The device is functioning as designed.Based on this information, no further action is required.

Event Description

The sterile handle fell into the sterile field during surgery.No patient or caregiver 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: 9165767
• MDR Text Key: 194800003
• Report Number: 9681407-2019-00034
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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