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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XTEN; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS XTEN; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD567815999
Device Problems Crack (1135); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - xten.It was stated the plastic on the handle is crumbling at the end.It was confirmed by photographic evidence the handle is broken on the connection to the lighthead with crumbling plastic particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Initial reporter was getinge technician.Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
 
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Brand Name
XTEN
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
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 Key18957366
MDR Text Key338367577
Report Number9710055-2024-00227
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARD567815999
Device Catalogue NumberARD567815999
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2005
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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