MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED TRIO/QUAD; OPERATING LIGHT SYSTEM

Model Number 4028310

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the cover was reattached by the technical staff of the hospital after the event.A trumpf medical/ hillrom service technician will inspect all operating light systems within this facility.It is known that improper installation, maintenance, or collision can lead to the spring arm covers falling off.Trumpf medical is not aware of any serious injury, serious deterioration in the state of health of a patient, user or third person, or death as a result of this failure mode.Based on this information, no further action is required.

Event Description

The customer alleged an oled spring arm joint cover fell off during surgical procedure.No injury was reported.

• Brand Name: ILED TRIO/QUAD
• Type of Device: OPERATING LIGHT SYSTEM
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: florian denk ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9349587
• MDR Text Key: 202212762
• Report Number: 9681407-2019-00052
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4028310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2007
• 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