• 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 SATELITE HOLDER, CAMERA, SURGICAL

  • 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 SATELITE HOLDER, CAMERA, SURGICAL Back to Search Results
Model Number ARD568217113A - SUSPENSION
Device Problem Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is still being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2019 maquet sas became aware of an issue with one of devices- satellite. As it was stated, the paint is flaking off. There was no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off from the parts of surgical light into sterile field or during procedure may be a source of contamination.
 
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 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 reference number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSATELITE
Type of DeviceHOLDER, CAMERA, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
0332382587
MDR Report Key8752231
MDR Text Key149782141
Report Number9710055-2019-00210
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD568217113A - SUSPENSION
Device Catalogue NumberARD568217113A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-