MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5000 / 3000 CEILING DUO; SURGICAL LIGHT

Model Number 4038210

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Event Description

It was reported that a nurse moved the spring arm with radiation protection shield which was attached to the trulight surgical light as the spring arm separated from the support arm system and fell down.The falling component hit the nurse at the shoulder.No serious injury occurred in relation to the event.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The trulight surgical light was inspected by a field service technician.A new spring arm with radiation protection shield was installed at the trulight system.Further investigation is ongoing.

Manufacturer Narrative

It was reported that the mavig portegra spring arm (with radiation protection shield) which was connected to the trulight system detached and fell down hitting a nurse on the shoulder/arm.Ultrasound examination as well as x-ray scan of the right shoulder and right wrist joint were provided to the nurse with no findings of a serious injury.A bruising of the shoulder was confirmed.Following a shoulder joint orthosis was placed.Follow up with the customer notes that "the nurse is doing well so far" and is on sick leave for one week.Based on the report that the nurse is reportedly "doing well" it is reasonable to conclude that the event did not result in serious injury nor a permanent impairment of a body function or permanent damage to a body structure occurred.The trulight surgical light and mavig portegra spring arm with radiation protection shield was inspected by a field service technician.A further investigation of the inspection results identified the spring arm was was not installed correctly at the central axis.A necessary washer was missing which allowed the spring arm to detach from the central axis of the light system.In november 2021 the new trulight light system was installed at the customer location by trumpf medical.As a new mavig portegra spring arm was not immediately available, the customer requested to install as an interim solution the old mavig portegra spring arm form the old light system which was installed previously at this location.The root cause is considered as an installation failure of the old mavig portegra spring arm at the new trulight light system.Remedial action: after the event a new mavig portegra spring arm with radiation protection shield was installed at the trulight surgical light.The service organization was informed about the event to ensure a correct installation according to the installation manual.Based on the above findings no further action is required.

Event Description

It was reported that a nurse moved the spring arm with radiation protection shield which was attached to the trulight surgical light as the spring arm separated from the support arm system and fell down.The falling component hit the nurse at the shoulder.No serious injury occurred in relation to the event.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TRULIGHT 5000 / 3000 CEILING 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: 13715002
• MDR Text Key: 290973752
• Report Number: 9681407-2022-00004
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995918
• UDI-Public: 887761995918
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/05/2022

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: 4038210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 05/06/2022
• 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