MAUDE Adverse Event Report: MAQUET SAS XTEN

Model Number XTENDUODFV

Device Problems Crack (1135); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

The customer reported to maquet that the surgical light broke during use.According to the customer, the event happened during surgery but did not affect patient treatment.The broken light was part of a multiple unit configuration, so an additional illuminate was immediately available to complete the procedure.No injuries were reported.(b)(4).

Manufacturer Narrative

A field service technician visited the hospital and found the front pivot of the spring arm was broken at the weld seam.He replaced the spring arm with a new one and returned the unit to service.This malfunction was previously addressed in the u.S.Through the device correction.Maquet medical systems usa submits this report on behalf of the device manufacturing facility.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: XTEN
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET SAS; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3916478
• MDR Text Key: 20659029
• Report Number: 9710055-2014-00012
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/27/2014,01/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTENDUODFV
• Device Catalogue Number: 568221510C
• Other Device ID Number: 567801094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2014
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• 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