MAUDE Adverse Event Report: MAQUET SAS X-TEN; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 568244710C - X10VAXL+SF

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician (fst) evaluated the device and found that the metal dust cover of the light system was dislodged.Maquet assumes that the device failed to meet its specification due to an incorrect attachment of the dust cover or a detachment due to repeated collisions.Additionally, it device was directly involved with the event and was being used for treatment or diagnosis of the patient when the event occurred.The xten series installation program includes a verification of all covers of the device.

Event Description

The customer reported that during a surgery, the dust cover came off from the spring arm.There was no patient involved and there was no injury reported.(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician replaced the metal dust cover with a new one.

Event Description

(b)(4).

• Brand Name: X-TEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - 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 ; 0332382587
• MDR Report Key: 6174098
• MDR Text Key: 62684877
• Report Number: 9710055-2016-00104
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 568244710C - X10VAXL+SF
• Device Catalogue Number: 567910923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2010
• 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