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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDVCS209004A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
 
Event Description
On 29th march, 2021 getinge became aware of an issue with one of surgical lights - volista access.The dust cover of the spring arm fell off.We are not aware of any injury this has caused however we decided to report the issue based on the potential as detachment of any component may cause risk of contamination of sterile field.
 
Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access.The dust cover of the spring arm fell off.We are not aware of any injury this has caused however, we decided to report the issue based on the potential as detachment of any component may cause risk of contamination of sterile field.It was established that when the event occurred, the surgical light did not meet its specification as dust cover should not detach - and therefore it contributed to incident.There is no indication that at the time when the event occurred, the device was being used for patient treatment or diagnosis.The manufacturer¿s subject matter experts have investigated the issue.The possible root causes of the issue with dust covers are: non-conformity of the metal covers¿ assembly.Degradation of the metal covers.Improper use (collision with another device) according to technician who was at site the issue occurred due to device misuse by the customer.In the scope of our continuous improvement policy, maquet sas initiated a modification file to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name
VOLISTA ACCESS
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key11731956
MDR Text Key247564391
Report Number9710055-2021-00146
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/20/2021
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 Operator No Information
Device Model NumberARDVCS209004A
Device Catalogue NumberARDVCS209004A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/27/2021
Supplement Dates Manufacturer Received05/04/2021
Supplement Dates FDA Received05/20/2021
Patient Sequence Number1
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