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

Model Number	ARDVCS209042A
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	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Event site postal code: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 13th may, 2024 getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the keypad disconnects and falls down.It was confirmed by video evidence that front layer of keypad was detached and taped to prevent it from falling.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.
Additional Manufacturer Narrative
Initial reporter was ot technician.The correction of adverse event awareness date and b5 describe event and problem deems required.This is based on the internal evaluation.On 13th may, 2024, getinge became aware of an issue with one of surgical lights - volista access ii, but information about reportable issue (the keypad disconnects and falls down) was provided on 4th june 2024 (adverse event awareness date).Previous b5 describe event and problem: on 13th may, 2024, getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the keypad disconnects and falls down.It was confirmed by video evidence that front layer of keypad was detached and taped to prevent it from falling.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.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the keypad disconnects and falls down.It was confirmed by video evidence that front layer of keypad was detached and taped to prevent it from falling.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.Defective part was replaced by vcs2-400/600 - light head keypad with tk (ard368877555).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 claimed device was not being used for patient treatment or diagnosis when the event took place.A root cause analysis for investigated problem was performed by subject matter experts and concluded that: the fact that the keypad detached remains an isolated case for this range of light (vcsii).So far, the root cause cannot be established.Nevertheless, the supplier has been informed about this problem.So far, no new cases have been recorded.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the keypad disconnects and falls down.It was confirmed by video evidence that front layer of keypad was detached and taped to prevent it from falling.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.

• Brand Name: 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: 20415451
• Report Number: 9710055-2024-0000553
• Device Sequence Number: 8202776
• Product Code: FSY
• UDI-Device Identifier: 03700712420758
• UDI-Public: (01)03700712420758
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/10/2024

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: ARDVCS209042A
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown