MAUDE Adverse Event Report: MAQUET SAS XTEN; LIGHT, SURGICAL, CEILING MOUNTED

Model Number XTENDFDUOV

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

On 03/24/2016 03:27 pm (gmt+1:00) added by (b)(6): maquet examined the device and determined that the light head detached because the spring arm was broken at the welding.The defective spring arm was repaired and the device returned to service.This malfunction was previously addressed in the u.S.Through the device correction noted.

Event Description

On 03/24/2016 03:02 pm (gmt+1:00) added by (b)(6): the customer reported that the cupola detached and fell next to the patient on the floor while it was manipulated during a surgery.No injuries were reported.(b)(4).

• Brand Name: XTEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MARIE-FRANÇOISE CABEL - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074
• MDR Report Key: 5523541
• MDR Text Key: 41525578
• Report Number: 9710055-2016-00019
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K040735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTENDFDUOV
• Device Catalogue Number: 568223510C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0182/188-2010
• Patient Sequence Number: 1