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

Catalog Number LUSX10DDFVMSS

Device Problems Loss of Power (1475); Failure to Power Up (1476)

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

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On (b)(6) the maquet (b)(4) become aware of the incident with the surgical light xten device.It was stated by the customer that the light "shut off during a case (b)(6) 2017 and won't turn on".Besides our best efforts we were no able to establish whether this happened during the surgery or daily check, if it was the only light in the room.Therefore we report this event in abundance of caution.There was no injury reported.Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas received a customer complaint where, as stated, the light turned off during a procedure and then it did not turn on again.Investigation was performed on the issue.It was found that when the issue occurred the device was not up to its specification and it contributed to the event.No injury has been reported.The device was being used for patient treatment at the time of the event.Due to lack of information exact root cause of the failure could not be established.User manual for x¿ten devices (en 0130103, 3a) includes information about maintenance steps which need to be taken to keep the device up to its specification.Mentioned manual includes description of the steps which need to be done daily by the user and it include instruction which need to be taken by the customer.All of mentioned above information helps to prevent unexpected situation during the procedure.However it remains possible -although unlikely- for an escalation of factors to occur that causes a normal wear situation, of the components that are of a consumable nature, to cause an event as the one reviewed here.Working from the assumption the customer followed the iec60061 standard relating to or installation, a second cupola would have been in use, which would have been sufficient to carry out the procedure with.However the first indication showed that the issue occurred during the operation we decided to report this case in abundance of caution.

Event Description

Manufacturer reference number (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: 6598021
• MDR Text Key: 76388538
• Report Number: 9710055-2017-00039
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K040735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LUSX10DDFVMSS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/02/2017
• 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