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

Catalog Number ARD5678010

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

We are aware that this is past the 30 day deadline for reporting.We have reminded the complaint handler to review fda reporting guidelines in order to prevent this from happening again.The issue is being investigated by manufacturing site.(b)(4).

Event Description

On (b)(4) 2018 maquet sas became aware of an incident with one of surgical lights- x-ten.As stated, a flange of spring arm has torn off.There is no injury reported however we decided to report the issue in abundance of caution as any part falling might cause an injury.(b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of the issue with one of the x-ten surgical lights.As it was stated, a flange of spring arm has torn off.There is no injury reported however we decided to report the issue in abundance of caution as any part falling might cause an injury.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.There is no information provided if during the event occurrence, the device was or was not being used for patient treatment.During this investigation, it was established that the reported issue has never resulted in a serious injury or worse.The breakage appeared due to the tearing of the spring arm tube on the edge of the welding joint.The spring arm used in the device is of production year 2005.The spring arm design was adapted by increasing the thickness of the tube from 2006 production onwards.The old version of the tube has 1,35 mm of thickness, whereas the new version of tube has 2,35 mm.As a result, the external diameter of tube has increased to 34 mm.To prevent any other similar incident we have addressed this issue with a previous field action msa-2009-003-iu[z-0182/188-2010] and since we see recurrence of the events - as we received new complaints from certain markets where these devices are still in use- we started a new field action msa-2017-002-iu.The device involved was confirmed to be part of the consignee list and therefore was planned to be updated, however the update did not take place yet.The defective part was replaced after the issue occurrence.The planning of the field action is done device per device, based on the device availability: due to the field action activity the use of the customer facility or faces downtime, which is hard to fit in our customer¿s schedules.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet (b)(4).

• Brand Name: X-TEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8019949
• MDR Text Key: 125675590
• Report Number: 9710055-2018-00144
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD5678010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1