MAUDE Adverse Event Report: MAQUET SAS MAQUET ROLITE; LIGHT, SURGICAL, FLOOR STANDING

Model Number	ARDROL309031A
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	08/23/2023
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 (b)(6) 2023 getinge became aware of an issue with one of surgical lights - rolite volista access.It was stated the iron between the support arm of the mobile volista lamp and the lighthead is in a broken condition.There was no injury reported, however, we decided to report the issue in abundance of caution as this broken connection could lead to detachement of the headlight and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
The initial reporter was hospital biomedical technician.The correction of b5 describe event and problem and d4 unique identifier (udi) # deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 23th august, 2023 getinge became aware of an issue with one of surgical lights - rolite volista access.It was stated the iron between the support arm of the mobile volista lamp and the lighthead is in a broken condition.There was no injury reported, however, we decided to report the issue in abundance of caution as this broken connection could lead to detachment of the headlight and as a result of that, could lead to serious injury.Corrected b5 describe event and problem: on 23th august, 2023 getinge became aware of an issue with one of surgical lights - rolite volista access.It was stated, and confirmed with photographic evidence, the iron between the support arm of the mobile volista lamp and the lighthead is in a broken condition.There was no injury reported, however, we decided to report the issue in abundance of caution as this broken connection could lead to detachment of the headlight and as a result of that, could lead to serious injury.Previous d1 brand name: rolite volista access corrected d1 brand name: maquet rolite previous d2a product code: fsy corrected d2a product code: fss previous d2b common device name: light, surgical, ceiling mounted corrected d2b common device name: lamp, surgical, floor standing previous d4 catalog # ard568805900 corrected d4 catalog #: none previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4) the correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.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 surgical lights - rolite volista access.It was stated, and confirmed with photographic evidence, the iron between the support arm of the mobile volista lamp and the lighthead is in a broken condition.There was no injury reported, however, we decided to report the issue in abundance of caution as this broken connection could lead to detachment of the headlight and as a result of that, could lead to 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.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: expertise of the volista 400 sf light head ard568805900 sn (b)(6) (assembled in sept 2022) returned by rma23051964 : several breakage were found in the connection plane of the adc12 aluminum structure ard568802016.The link between the ard568802057 axle and the ard568802016 structure is provided by 3 ard599905006 m5x16 chc pre-glued screws and 3 ard602420595 z5 washers tightened to a production torque of 4.5 n/m ±10%.Observation of the connection plan for the structure in question shows that the pre-glued screws and washers were present on the assembly, as the surfaces of the structure are marked by the washers.The connection plane of the structure shows no anomalies (no cracks in the casting, no lack of material).No traces of impact were observed on the light head.The user reported that the device had not been misused.There are 2 probable causes of breakage: excessive effort during use or maintenance.Partial tightening of one of the fixing screws during assembly in production.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
On 23th august, 2023 getinge became aware of an issue with one of surgical lights - rolite volista access.It was stated, and confirmed with photographic evidence, the iron between the support arm of the mobile volista lamp and the lighthead is in a broken condition.There was no injury reported, however, we decided to report the issue in abundance of caution as this broken connection could lead to detachment of the headlight and as a result of that, could lead to serious injury.

• Brand Name: MAQUET ROLITE
• Common Device Name: LIGHT, SURGICAL, FLOOR STANDING
• 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: 17676629
• Report Number: 9710055-2023-00621
• Device Sequence Number: 20397560
• Product Code: FSS
• UDI-Device Identifier: 03700712417062
• UDI-Public: (01)03700712417062
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023
• 2 Devices were Involved in the Event: 1 2

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: ARDROL309031A
• Device Catalogue Number: ARD568805900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown