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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XTEN DUO; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS XTEN DUO; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568211210C
Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2023
Event Type  malfunction  
Event Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated the top securing bolt has snapped.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 or serious injury.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site telephone: (b)(6).Device not returned to the manufacturer.
 
Event Description
On 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated one of the top securing bolt has snapped upon the device inspection.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
 
Manufacturer Narrative
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event and problem and d4 catalog # deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated the top securing bolt has snapped.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 or serious injury.Corrected b5 describe event and problem: on 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated one of the top securing bolt has snapped upon the device inspection.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Previous d4 catalog #: ard568211210c.Corrected d4 catalog #: ard56782399.
 
Event Description
On 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated one of the top securing bolt has snapped upon the device inspection.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.During further analysis of this complaint, it was found that such an issue could not occur during everyday use of the lamp, and only occurred because specific device inspection activities were performed by the technician.Therefore, the scenario described in the record is considered as non-reportable.
 
Manufacturer Narrative
Event site telephone: (b)(6).The correction of b5 describe event and problem and h6 medical device - problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated one of the top securing bolt has snapped upon the device inspection.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Corrected b5 describe event and problem: on 22nd june, 2023 getinge became aware of an issue with one of surgical lights - xten duo.It was stated one of the top securing bolt has snapped upon the device inspection.There was no injury reported, however, we decided to report the issue in abundance of caution as broken screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.During further analysis of this complaint, it was found that such an issue could not occur during everyday use of the lamp, and only occurred because specific device inspection activities were performed by the technician.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device - problem code: mechanical problem|detachment of device or device component||2907.Corrected h6 medical device - problem code: no apparent adverse event|||3189.Initially provided information was pointing to the top securing bolt which has snapped.The issue was considered as safety related as as any parts falling off into sterile field or during procedure may cause serious injury.According to the further analysis of this complaint it was determined that the issue investigated herein is not safety and risk related as the issue occurred during service.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.
 
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Brand Name
XTEN DUO
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 Key17197426
MDR Text Key317810759
Report Number9710055-2023-00472
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup,Followup
Report Date 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568211210C
Device Catalogue NumberARD567823999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received06/26/2023
Supplement Dates Manufacturer Received07/05/2023
11/29/2023
Supplement Dates FDA Received07/21/2023
12/12/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/16/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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