MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number 4068310

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The customer alleged the light head was dropped.The bio med went to secure the light head to the spring arm and it fell to the floor.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

Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.

Event Description

The customer alleged the light head was dropped.The bio med went to secure the light head to the spring arm and it fell to the floor.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

During follow-up with the customer it was identified the light head fell during the maintenance procedure carried out by the hospital biomed.For maintenance it is required to remove the light head from the support arm system.During this, the light head fell based on a handling failure of the technician.There was no impact to a surgical procedure and no identified device malfunction.Mthe defect light head will be replaced.Based on this, not further actions are required.

• Brand Name: ILED 7 CEILING TRIO
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• Manufacturer Contact: frances coote ; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 15518513
• MDR Text Key: 306362156
• Report Number: 9681407-2022-00023
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• 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