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

Model Number 4068310

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

The adaption control handle was exchanged as it was believed to be the root cause.The part will be investigated.

Event Description

One of the sterile handles did not lock properly to the adaptation control handle.During surgery, it fell from its lock and landed sterile end first onto the patient's stomach.No injury reported.

• Brand Name: ILED 7 TRIO / QUAD
• 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: 9088436
• MDR Text Key: 202966203
• Report Number: 9681407-2019-00028
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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