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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 ARD567801999/ARD56780999
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On 21st december, 2023 getinge became aware of an issue with one of surgical lights - xten.As it was stated, the handles are crumbling.The designated complaint unit employee confirmed based on photographic evidence the headlight handle was cracked with missing particles.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 in case of reoccurrence.
 
Manufacturer Narrative
The initial reporter was getinge technician.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
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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 Key18407951
MDR Text Key331480407
Report Number9710055-2023-00985
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 12/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD567801999/ARD56780999
Device Catalogue NumberARD567801999/ARD56780999
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/21/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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