MAUDE Adverse Event Report: MAQUET SAS STANDOP VOLISTA®; LAMP, SURGICAL

Model Number	ARD267900100A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Initial reporter: #person in charge additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 28th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the dust cover was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, h4 manufacture date, d4 catalog #, d4 unique identifier (udi), h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain deems required.This is based on the internal evaluation.Previous d1 brand name: volista standop.Corrected d1 brand name: standop volista®.Previous d4 catalog #: ard267900100a.Corrected d4 catalog #: vst66df tk aim xs12 spe.Previous d4 unique identifier (udi) #: blank.Corrected d4 unique identifier (udi) #: (b)(4).Previous h4 manufacture date: 2019-11-26.Corrected h4 manufacture date: 2019-11-27.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the dust cover was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Missing part was replaced (ard315021555- sat-ondaspace df-sf 4 dust covers kit), and device returned to usage.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since spring arm metal cover detachment could be considered as technical deficiency, and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.According to subject matter expert at manufacturer¿s, the most probable root causes are: non-conformity of the metal covers assembly.Degradation of the metal covers.Improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (b)(4) to include this dust cover fitting procedure in the technical documentations with all spring arms.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: LAMP, SURGICAL
• 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: 18835670
• Report Number: 9710055-2024-00189
• Device Sequence Number: 7214891
• Product Code: FTD
• UDI-Device Identifier: 03700712406004
• UDI-Public: (01)03700712406004
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K130513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARD267900100A
• Device Catalogue Number: VST66DF TK AIM XS12 SPE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown