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

Device Problem Loss of Power (1475)

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 the (b)(6) 2017 maquet sas became aware of an incident with xten device.As it was stated during lowering of the light the power was cut off.(b)(4).

Manufacturer Narrative

Maquet sas received complaint where, as stated, the light turned off during a surgery when it was being lowered by the user.No injury has been reported due to this failure.Investigation was performed on the issue.There is no trend for this particular issue, we can assume that the issue is not a systematic failure, rather single issue.It was found by the technician visiting the site that the device which played role in the investigated herein issue was not up to its specification and it contributed to the event.The root cause of the failure has been evaluated as most likely being a combination of below factors: ageing of the electrical components and material.Burning of the connector as a result of a voltage occurring in the cables during manipulation of the device that went to a level so high it burned the connector.Possible not following daily routine to check the device functioning correctly before use.Manipulating the device during a surgery, while the recommendation is to set it up beforehand.Please note that the device was in use for 10 years that the event took place, the parts of the device including electrical connectors and cables are subjects of wear and tear, device should perform correctly but only in the situation that was maintained correctly.User manual for x¿ten devices (en (b)(4), 3a) includes information about maintenance steps which need to be taken to keep the device up to its specification.Mentioned manual include information that ¿the light should be positioned prior to any procedures to avoid having to move it more than necessary later on.Correctly positioning the light for each operation will limit the chances of it coming into contact with other objects (iv pole, pendant, etc.).¿ typically a surgical light is providing shadow-free light to such a degree that once positioned, repositioning is not normally required.All of mentioned above information helps to prevent unexpected situations during the procedure.We do not have information that the daily routine was kept and performed before the event occurred, we cannot rule out that the daily maintenance procedure was omitted or was not performed correctly by the customer.The received information indicated that an issue occurred during the operation which made us decide to report this case in abundance of caution.

Event Description

Ref (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: 6548054
• MDR Text Key: 74680464
• Report Number: 9710055-2017-00028
• 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
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: Reuse
• Patient Sequence Number: 1