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

Model Number	ARD2STP00070A
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	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 2th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the protective cover was missing.There is no information about the circumstances of the missing part.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Event or Problem Description
On 29th january, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the protective cover and dust cover were missing.There is no information about the circumstances of the missing part.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The biomed technician informed getinge about problem.The correction of b3 date of event, b5 describe event and problem, d1 brand name, d4 version of model #, 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 b3 date of event 02/02/2024.Corrected b3 date of event 01/29/2024.Previous b5 describe event and problem: on 2th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the protective cover was missing.There is no information about the circumstances of the missing part.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 29th january, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista standop.As it was stated the protective cover and dust cash were missing.There is no information about the circumstances of the missing part.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Previous d1 brand name: volista standop.Corrected d1 brand name: standop volista®.Previous d4 version of model # ard568821960.Corrected d4 version of model # ard2stp00070a.Previous d4 catalog # ard568821960.Corrected d4 catalog # vst40df hor spe.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).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 protective cover and dust cash were missing.There is no information about the circumstances of the missing part.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since cover detached or missing could be considered as technical deficiencies, 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 incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.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: 18720052
• Report Number: 9710055-2024-00155
• Device Sequence Number: 4525977
• Product Code: FTD
• UDI-Device Identifier: 03700712405854
• UDI-Public: (01)03700712405854
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: ARD2STP00070A
• Device Catalogue Number: VST40DF HOR SPE
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown