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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS SATELITE HOLDER, CAMERA, SURGICAL

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MAQUET SAS SATELITE HOLDER, CAMERA, SURGICAL Back to Search Results
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided upon results of investigation. It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system. Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner. Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints. Device not returned to manufacturer.
 
Event Description
On 17th of october 2018 getinge became aware of an issue with one of our surgical lights. As stated, there was corrosion detected on arms. No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as detachment of any paint or rust particles may lead to contamination of sterile field. Manufacturer's reference number (b)(4).
 
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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 
MDR Report Key10391233
MDR Text Key202414114
Report Number9710055-2020-00295
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/07/2020
Was Device Evaluated by Manufacturer? No
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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