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

Model Number	ARDSAT209018A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12th august, 2024 getinge became aware of an issue with one of surgical lights - volista standop.It was stated and confirmed by photographic evidence the lamp head was broken at joint.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
(b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name deem required.This is based on the internal evaluation.Previous d1 brand name: standop volista.Corrected d1 brand name: standop volista®.Getinge became aware of an issue with one of surgical lights - volista standop.It was stated and confirmed by photographic evidence the lamp head was broken at joint.We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered during operating room preparation.As stated by subject matter expert at the manufacturing site, getinge received customer product complaint where the junction between headlight and fork was broken on a volista cupola.It was reported that no external damages were noticed on the device.However, it can be observed that the framework of the light head made of aluminium is completely torn out.At the breakage location the main screws are not loose but one of them is bent.There is no doubt that this breakage is the result of an important strength applied on the device.The fact that no external damages were noticed shows that the most probable cause is that someone took the headlight with hands and applied a big strength in the down direction.This is here clearly a misuse.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: STANDOP VOLISTA®
• Common Device Name: 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 Key: 20051165
• Report Number: 9710055-2024-00483
• Device Sequence Number: 7955332
• Product Code: FSY
• UDI-Device Identifier: 03700712405496
• UDI-Public: (01)03700712405496
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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 Number: ARDSAT209018A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown