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

Model Number	ARDVCS209005A
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	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 27th april, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the spring arm rod was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
Event or Problem Description
On 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.The failure was evident during a diagnostic visit.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The initial reporter was distributor.The correction of e1b event site name, b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the spring arm rod was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 27th april 2024, getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.The failure was evident during a diagnostic visit.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d4 catalog#: ardvcs209005a, corrected d4 catalog#: none, previous d4 unique identifier (udi)#: n/a, corrected d4 unique identifier (udi)#: (b)(4).Getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the lower elbow of spring arm was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.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 device was being used for patient treatment upon the event occurrence.The breakage has probably been caused by an important shock due to the spring arm release when it was in low position and without the light head.The direct consequence of this incident is the breakage of the covers of the spring arm.This incident is due to in improper use of the spring arm during an installation or maintenance procedure.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: VOLISTA ACCESS
• 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: 19211705
• Report Number: 9710055-2024-00309
• Device Sequence Number: 8194517
• Product Code: FSY
• UDI-Device Identifier: 03700712401313
• UDI-Public: (01)03700712401313
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/30/2024

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: ARDVCS209005A
• Device Catalogue Number: ARDVCS209005A
• 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: 04/27/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown