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 Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

The hosp reported that during a surgical operation, the medical staff heard an abnormal noise from the spring arm when positioning the light head.After the operation, the hosp engineer found a large crack at the joint between the light head and spring arm.No injuries were reported.(b)(4).

Manufacturer Narrative

This malfunction was previously addressed in the us.The light has been removed from the svc pending repair.

• Brand Name: XTEN
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET SAS; avenue de la pomme de pin; parc de limere; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3905231
• MDR Text Key: 4430178
• Report Number: 9710055-2014-00034
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/28/2014,04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• 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: 05/15/2014
• Device Age: 9 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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