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

Model Number ARDVCS209003A

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 15th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the piece was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any pieces falling off into sterile field or during procedure may cause contamination.

Event Description

On 15th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the piece was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any pieces falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that there was no visible damage and no parts were missing.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing pieces, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The correction of b5 describe event and problem, h6 medical device ¿ problem code, h6 investigation findings, h6 component codes and h6 investigation conclusions deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 15th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the piece was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any pieces falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 15th february, 2024 getinge became aware of an issue with one of our surgical lights ¿ volista access.As it was stated the piece was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any pieces falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that there was no visible damage and no parts were missing.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing pieces, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: no device problem found|||213 previous h6 medical device ¿ component codes: mechanical|cover||772 corrected h6 medical device ¿ component codes: none previous h6 investigation conclusions: conclusion not yet available||11 corrected h6 investigation conclusions: no problem detected||67 initially provided information was pointing to missing pieces.The issue is considered as safety related as any parts or particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no visible damage, no parts were missing and the equipment is suitable for clinical use.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: VOLISTA ACCESS
• Type of Device: 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: 18729967
• MDR Text Key: 336746692
• Report Number: 9710055-2024-00162
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: ARDVCS209003A
• Device Catalogue Number: ARDVCS209003A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1