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Model Number ARD568821961
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
Event Description
On 19th july, 2021 getinge became aware of an issue with one of surgical lights ¿ volista standop. One of the screws for cover of spring arm was missing. There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the screw may lead to the contamination of the sterile field.
Event Description
Manufacturer reference number (b)(4).
Manufacturer Narrative
It was established that when the event occurred, the surgical light did not meet its specification since a screw was loosened, and it contributed to the reported situation. There is no information if the device was or was not being used for patient treatment at the time when the event occurred. During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse. Sme performed an investigation. The manufacturer of spring arms led tests with a loosen screw with a complete turn back, which showed that it is the only case where the screw continue to loosen. The loosening detected on a period less than 1 year after the installation therefore appears to correspond to a manufacturing issue, due to an incorrect initial tightening during assembly. The cases detected after more 1 year after the installation, in contrast correspond to a lack of inspection during the yearly preventive maintenance. Conclusions show, that most probable root cause of loosen screw is a lack of inspection during the yearly preventive maintenance, as because during such maintenance such loose fastener would be detected, since the maintenance schedule requires a visual check. As improvement measure, the spring arms covers are assembled, on the product line, with tuflok coated screws. In any case, by design, the nylon patch of these screws acts as a mechanical locking and prevents the loosening and the fall of the screw. We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
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Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
parc de limere
avenue de la pomme de pin
MDR Report Key12224952
MDR Text Key263393186
Report Number9710055-2021-00250
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,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD568821961
Device Catalogue NumberARD568821961
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device?