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

Model Number X10SFLIGHTHEAD

Device Problem Material Deformation (2976)

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

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

The technician evaluated the device and assumes that the paint failure is due to a cleaning agent used to cleaning the device.The investigation is on-going and the result will be included in a follow-up report.

Event Description

The customer reported that during a surgery, particles of paint are fallen from the lighthead and they noticed presence of bubbling on the lighthead.No injuries to the patient reported.(b)(4).

Manufacturer Narrative

Maquet evaluated the device and noticed that the deterioration of the paint is far advanced and must have started years ago.The multiple paint touch up on the cupola is an evidence of this.Maquet assumes that this event is the result of the use of inappropriate cleaning agents.Per the labeling, users should "check the lightheads for chipped paint, impact marks and any other damage" on a daily basis prior to using the device.In addition, the xten operating manual provides instructions regarding cleaning and disinfecting practices.The device does not remain conform to its specification.The device was directly involved with the reported incident and was being used for treatment or diagnosis of the patient when the event occurred.The customer installed a temporary seal over the chipped area, pending the repair that is planned during the first quarter 2017.

Event Description

(b)(4).

• Brand Name: XTEN
• 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: 5988472
• MDR Text Key: 56545307
• Report Number: 9710055-2016-00085
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X10SFLIGHTHEAD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2008
• 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