MAUDE Adverse Event Report: MAQUET SAS MAQUET EQUIPMENT; HOLDER, CAMERA, SURGICAL

Model Number	ARDEQT269002A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th august 2023 getinge became aware of an issue with one of our equipments ¿ hor 14 xo.According to the photographic evidence, dust and rear covers, as well as cap with a fixing screw were missing.Additionally, spring arm covers were damaged with missing particles.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
Additional information will be provided following the conclusion of the investigation.E1a initial reporter, event site name: (b)(6).H3 other text: device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our equipments ¿ hor 14 xo.According to the photographic evidence, dust and rear covers, as well as cap with a fixing screw were missing.Additionally, spring arm covers were damaged with missing particles.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.It was established that when the event occurred, the equipment did not meet its specification and in this way the device contributed to event.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.According to the photo it can be noticed that the remaining half cover is broken.The root cause of the missing parts is then a shock with other devices in the operating room.The missing spring arm covers (rear cover and dust cover) were probably removed or detached during a collision.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.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.The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d4 catalog # and model # ardeqt269002a corrected d4 catalog # and model # n/a.

• Brand Name: MAQUET EQUIPMENT
• Common Device Name: HOLDER, CAMERA, SURGICAL
• 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: 17709385
• Report Number: 9710055-2023-00664
• Device Sequence Number: 20578475
• Product Code: FXR
• UDI-Device Identifier: 03700712400989
• UDI-Public: (01)03700712400989
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/08/2023

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: ARDEQT269002A
• Device Catalogue Number: ARDEQT269002A
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown