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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS G8E LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS G8E LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Device Problems Component Falling (1105); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2017
Event Type  Malfunction  
Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4). A follow-up medwatch will be submitted when additional information is received.

 
Event Description

On (b)(6) 2017 maquet (b)(4) became aware of incident with one of devices-- surgical light g8 evolution. It was stated that during surgery arms got hit each other and the cover of one of spring arm fell off. No adverse effect on the patient was reported however we decided to report this issue in abundance of caution. 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).

 
Event Description

Manufacturer reference number: (b)(4).

 
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Brand NameG8E
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 Key6852915
MDR Text Key85763833
Report Number9710055-2017-00059
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
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 Reuse

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