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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS SINGLE SCREEN HOLDER HOLDER, CAMERA, SURGICAL

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MAQUET SAS SINGLE SCREEN HOLDER HOLDER, CAMERA, SURGICAL Back to Search Results
Model Number ARD567506996
Device Problem Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 9th december, 2020 getinge became aware of an issue with single screen holder. As it was stated, the rust occurred on the device. There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
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Brand NameSINGLE SCREEN HOLDER
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 Key11044714
MDR Text Key241255867
Report Number9710055-2020-00512
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567506996
Device Catalogue NumberARD567506996
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 Received02/17/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/11/2015
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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