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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS SW OPERATING LAMPS HOLDER, CAMERA, SURGICAL

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MAQUET SAS SW OPERATING LAMPS HOLDER, CAMERA, SURGICAL Back to Search Results
Model Number ARD567508999 - ACCESSORIES
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2019 getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field. The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report this claim.
 
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Brand NameSW OPERATING LAMPS
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 Key9390366
MDR Text Key178199999
Report Number9710055-2019-00340
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Reporter Country CodeBE
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 06/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567508999 - ACCESSORIES
Device Catalogue NumberARD567508999
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 Received05/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/24/2009
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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