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

Model Number 1565160

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

The customer alleged the monitor fell off the spring arm from the surgical light system.No harm or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The on-site device investigation identified that the crescent key and groove of the flat panel bracket shaft was worn, which resulted in the separation of the flat panel bracket.The monitor bracket came loose from the spring arm and was being held up by its wires.The event occurred overnight when no one was around.According to the device instructions for use the crescent key needs to be inspected every two years for any wear.If further information will become available, a follow-up report will be submitted.Based on this information, no further action is required.

• Brand Name: ILED 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: 13017502
• MDR Text Key: 282329867
• Report Number: 9681407-2021-00037
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1565160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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