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

Model Number 1574850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

The trulight 5000/3000 lighting system is intended to locally illuminate an operating or examination area of the patient¿s body with light emitting diodes (leds) and can be used in a clinic or doctor¿s office.The device ifu states the following on light intensity: the luminaire¿s light intensity can be adjusted under fully sterile conditions by simple fingertips on the sterile hand grip with sterile light control function.In the area below the collar of the sterile hand grip, a motion sensor is installed in order to adjust the light intensity.To increase the light intensity: move your fingertips from left to right; to reduce the light intensity: move your fingers from right to left.The device uses lux to measure the light level of intensity.Lux is the unit of illuminance, or luminous flux per unit area, in the international system of units (si).Requirements for the device not to exceed 160,000 lux can be noted in standard en 60601-2-41, requirements for the safety of surgical luminaires and luminaires for diagnosis.Hillrom devices are compliant to this standard via chapter 1.7.2, standards & directives of the ifu, therefore the 160,000 lux must be ensured by the point user.The device ifu states the following on high illuminance and overlapping luminous fields: the high illuminance of the light heads ensures that surgeons have good visibility.Due to physical characteristics, visible light also creates heat in the surgical field.Overlapping luminous fields of multiple light heads produce high irradiance, which could cause tissue dehydration and particularly given extended exposure and reduced circulation, tissue damage.If a patient starts to suffer from poor circulation or tissue dehydration, separate overlapping luminous fields of multiple light heads and reduce the illuminance.The device ifu states the following on working range: the lighting system operates at 70-150 cm from the intervention site and is suitable for continuous operation.The following is noted in the device ifu on maintenance: all equipment is subject to wear over time.The safety and function of your equipment must therefore be checked via inspection and maintenance intervals.(1) a visual inspection of the entire lighting system must be performed by qualified operator personnel once a year.In particular, the following device parts and components must be checked for material deteriorations during this visual inspection: deformation of the components of the light head and the pendant system, defects in paint work on the entire pendant system and the light heads, missing plastic components and small parts, e.G., covers or plugs, formation of cracks or plastic parts becoming brittle, readability of the rating plates.(2) two-year maintenance intervals: the device must only be serviced by the trumpf customer service or an authorized partner.The device must be tested as regards to the following: test for proper functioning and electrical safety test.Inspection of the device by a hillrom technician found the trulight lighting system to be functioning as designed.In this event, the patient required medical and surgical intervention (hospitalization & skin grafts) to preclude permanent impairment of a body function or permanent damage to a body structure, therefore meets the definition of a serious injury.The device was inspected and functioned as intended.Based on this, no further action is necessary.

Event Description

It was reported that during use of the trulight lighting system a patient received knee burns requiring subsequent skin grafts.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT DUO TUSM
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15938895
• MDR Text Key: 305046277
• Report Number: 9681407-2022-00026
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1574850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/08/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 83 KG