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

Catalog Number ARD567827999

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

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

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On (b)(6) maqet sas became aware of an incident connected with the x-ten surgical light.As it was stated by the customer during the cleaning of the device its light head fell off.No injury was reported as a result of the incident.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light xten device.It was stated that during the cleaning the light head fell off.It was established that when the event occurred, the light-head did not meet its specification and it contributed to incident.In the time when the event occurred the device was not being used for patient treatment.During the investigation it was found that there is apparent trend with the issue at hand and that the reported scenario has to date never lead to serious injury or worse.Unfortunately, the originator did not provide any pictures of the light head nor any more information which can give a possibility to investigate the issue further.If we were to assume what caused the light head to fall off, our assumption would be that the spring arm has broken.The issue described in our assumption has been addressed with a new field action (msa/2017/002/iu) launched in october 2017.

Event Description

Manufacturer reference number (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: 6551162
• MDR Text Key: 74834994
• Report Number: 9710055-2017-00029
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD567827999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1