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

Model Number 1565160

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician inspected the device and replaced the elbow covers.The device is functioning as designed.It is known that improper installation, maintenance, or collision can lead to the spring arm covers falling off.Hillrom is not aware of any serious injury, serious deterioration in the state of health of a patient, user or third person, or death as a result of this failure mode.Based on this information, no further action is required.

Event Description

The customer alleged the spring arm elbow covers came off.No injury or impact to a surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ILED DUO TUSM
• 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: 10337558
• MDR Text Key: 202073439
• Report Number: 9681407-2020-00048
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1565160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2012
• 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