MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 3; SURGICAL LIGHT

Model Number 1605249

Device Problems Accessory Incompatible (1004); Electrical /Electronic Property Problem (1198); Compatibility Problem (2960); Power Problem (3010)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to evaluate the light system.The ground wires were inspected and the light appeared to be functioning properly; however, it was observed that when a bovie pencil is in use, the lights become dim.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Customer alleges that a trumpf medical iled 3 lamp head dims when a bovie pencil is in use.

Manufacturer Narrative

Following completion of the investigation, no technical problem with the iled 3/5 was found.The issue occurred when the bovie pencil was close to the light head and only in coagulation mode (operational frequency - 940hz), but not while on cut mode (operational frequency - 660hz).Prior to the event, the light system was re-configured to a low ceiling version.The light system was returned to the standard configuration after inspection and the unit is functioning as designed.Emc interferences are well known side-effects with surgical lights.The ifu of the iled 3/5 contains necessary distances between high frequency devices and the light system for different frequencies in which the device is operating.The device is compliant to the relevant emc standard.Based on this information, no further action is required.

• Brand Name: ILED 3
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9593274
• MDR Text Key: 202554633
• Report Number: 9681407-2020-00005
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1605249
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1