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

Catalog Number ARD567801150/ARD567201357

Device Problems Device Damaged by Another Device (2915); Material Integrity Problem (2978)

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

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

The issue is investigated by manufacturing site.(b)(4).

Event Description

On 20th february, 2018 maquet sas became aware of an incident with one of the surgical lights- xten.As stated by the customer, during surgery the spring arm of light head and spring arm of monitor support had a collision and paint fell off on the sterile instrumentation table.Furthermore, the paint chipping issue was also discovered on the suspension tube of the same surgical light.(b)(4).

Manufacturer Narrative

(b)(4) exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with a surgical light xten device.As stated by the customer, during surgery the spring arm of light head and spring arm of monitor support had a collision and paint fell off on the sterile instrumentation table.Furthermore, the paint chipping issue was also discovered on the suspension tube of the same surgical light.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.At the time when the event occurred, the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.As the preventive maintenance of the device is being made only by the hospital¿s personnel, the assumed root cause in the manufacturer¿s investigation is likely caused by a shock during a collision.The product xten user manual 0130103 ed.3a page 26 there is an information to daily check the device for chipped paint.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074.Exemption # e2018005.Getinge usa sales, llc (b)(4).Contact person: (b)(6).

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
• MDR Report Key: 7361297
• MDR Text Key: 103536838
• Report Number: 9710055-2018-00011
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD567801150/ARD567201357
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1