Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS; LAMP, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS VOLISTA ACCESS; LAMP, SURGICAL Back to Search Results
Model Number SU568801559A
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site.Device not returned to manufacturer.
 
Event Description
On 27th may, 2020 getinge became aware of an issue with one of surgical lights - volista access.As it was stated, the elastic ring was disconnected from the spring arm.There was no injury reported, however we decided to report the issue in abundance of caution as the disconnection of ring may lead to detachment of equipment.
 
Event Description
Manufacturers reference number: (b)(4).
 
Manufacturer Narrative
On 27th may, 2020 getinge became aware of an issue with one of surgical lights - volista access.As it was stated, the elastic ring was disconnected from the spring arm.There was no injury reported, however we decided to report the issue in abundance of caution as the disconnection of ring may lead to detachment of equipment.It was established that when the event occurred, the surgical light did not meet its specification due to the faulty connection between spring arm and fork and it contributed to the issue.It is unknown if the device was being used for patient treatment when the issue occurred.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.Unfortunately, the subject matter experts with the manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause nor to provide the most probable root causes.In case of new relevant information, the case will be reconsidered.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.It was observed during an external audit at getinge brazil, that servicing practices at getinge brazil are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge brazil has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VOLISTA ACCESS
Type of Device
LAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key10332098
MDR Text Key200608397
Report Number9710055-2020-00231
Device Sequence Number1
Product Code FTD
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSU568801559A
Device Catalogue NumberSU568801559A
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-