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

Model Number ARD568805908

Device Problems Break (1069); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - volista access.As it was stated during checks performed on the lamp, it was noticed that spring arm cover has come off.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.

Manufacturer Narrative

The correction of b5 describe event and problem, h6 medical device ¿ problem code, h6 investigation findings and h6 investigation conclusions deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.As it was stated during checks performed on the lamp, it was noticed that spring arm cover has come off.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.Corrected b5 describe event and problem: on 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.As it was stated during checks performed on the lamp, it was noticed that spring arm cover has come off.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.Further information provided by getinge employee indicated that the spring arm cover didn't came off, but was removed and no particles 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 fallen parts, 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 / material integrity problem|break||1069 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 investigation conclusions: conclusion not yet available||11 corrected h6 investigation conclusions: no problem detected||67 initially provided information was pointing to spring arm cover came off from device.The issue is considered as safety related as any parts falling off into sterile field or during procedure may cause contamination or serious injury.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 indication of cover came off- the spring arm cover was removed and no particles were missing.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.

Event Description

On 26th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.As it was stated during checks performed on the lamp, it was noticed that spring arm cover has come off.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.Further information provided by getinge employee indicated that the spring arm cover didn't came off, but was removed and no particles 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 fallen parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• 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: 18612821
• MDR Text Key: 334181232
• Report Number: 9710055-2024-00108
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 3700712420505
• UDI-Public: (01)3700712420505
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568805908
• Device Catalogue Number: ARD568805908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1