MAUDE Adverse Event Report: MAQUET SAS XS SINGLE FLAT SCREEN HOLDER; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 567506996

Device Problem Crack (1135)

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

Event Date 07/02/2018

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- xs flat single holder.As it was stated, the spring arm weld is cracked.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.

Event Description

(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.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

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.

Event Description

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

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still 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.

Event Description

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

Event Description

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

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.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 45 barbour pond drive wayne, nj 07470 contact person: (b)(4).

Event Description

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

Manufacturer Narrative

On (b)(6)2018 maquet sas became aware of an incident with one of xs flat single holders.As it was stated, the spring arm weld is cracked.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.During the event occurrence, the device was not being used for patient treatment.During this investigation it was established that the reported issue has resulted in a serious injury or worse.The issue was reviewed in details by the supplier of the spring arm.The front joint was found broken on both sides.Both fractures are beside the area of welding seam.The result shows that the defect is not a welding seam break but a material breach.The subject matter experts of the manufacturing site concluded that the breaking surface in the upper position demonstrates a crack initiation caused by an overstressing in the past.The dull finish area of fracture shows a recurrence overstressing that led to the complete breakage over time.According to these facts, supplier assumed that the defect were a result of improper use.

Event Description

Manufacturer's reference number 2018-60066.

• Brand Name: XS SINGLE FLAT SCREEN HOLDER
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8020499
• MDR Text Key: 125675530
• Report Number: 9710055-2018-00154
• Device Sequence Number: 0
• Product Code: FSY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 567506996
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 07/09/2018; 01/08/2020
• Supplement Dates FDA Received: 11/26/2018; 12/20/2018; 01/14/2019; 01/31/2019; 03/05/2019; 03/29/2019; 04/18/2019; 05/14/2019; 06/06/2019; 07/01/2019; 07/26/2019; 08/21/2019; 09/13/2019; 10/11/2019; 11/05/2019; 11/21/2019; 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1