MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7; SURGICAL LIGHT

Model Number 4037220

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician replaced the spring arm joint cover and 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 that the spring arm joint cover fell into the surgical field during a patient procedure.No injuries were reported in relation to this allegation.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: ILED 7
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; 7-9 carl zeiss strasse; saalfeld 07318 ; GM 07318
• MDR Report Key: 11250341
• MDR Text Key: 232599779
• Report Number: 9681407-2021-00003
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2021

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: 4037220
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/29/2021
• 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