• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS XTEN LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
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).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXTEN
Type of DeviceLIGHT, 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 Key7361297
MDR Text Key103536838
Report Number9710055-2018-00011
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK040735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 06/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberARD567801150/ARD567201357
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2018
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

-
-