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

Model Number 1565161

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

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician evaluated the device.It was identified during the inspection of the suspect device that the crescent key and groove of the flat panel bracket shaft was worn, which resulted in the separation of the flat panel bracket.Hillrom provided a repair proposal to the account to resolve the issue.Based on this information, no further action is required.

Event Description

It is alleged that the flat panel bracket was separating from the spring arm.No injury was reported.This report was filed in our complaint handling system as complaint #: (b)(4).

Event Description

It is alleged that the flat panel bracket was separating from the spring arm.No injury was reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

It was identified during the investigation that a third party company installed an optical video cable through the support arm after the initial installation of the light system by trumpf medical/hillrom.In installing the optical video cable through the support arm, the flat panel bracket was removed and installed again.The installation of the crescent key which holds the flat panel bracket was not performed correctly by the third party causing the flat panel bracket to separate from the spring arm.Hillrom provided a repair proposal to the account to resolve the issue.Based on this information, no further action is required.

• Brand Name: ILED TRIPLE TUSM
• 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: 10677710
• MDR Text Key: 211332414
• Report Number: 9681407-2020-00056
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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 Operator: No Information
• Device Model Number: 1565161
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/03/2020
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1