MAUDE Adverse Event Report: MAQUET SAS POWERLED TM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD268300170A
Medical Device Problem Codes	Crack (1135); 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 31st october 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the customer needs a ring.The designated complaint unit employee confirmed based on photographic evidence the headlight handle ring was cracked with missing particles.We decided to report the issue in abundance of caution as any parts particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.No future info available.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled.It was stated the customer needs a ring.The designated complaint unit employee confirmed based on photographic evidence the headlight handle ring was cracked with missing particles.We decided to report the issue in abundance of caution as any parts particles falling off into sterile field or during procedure may cause contamination.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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.A root cause analysis for the issue of broken handle rings was performed by the manufacturer¿s subject matter experts (sme) and according to their analysis: the light head is conforming to the standard iec 60601-2-41 and therefore the light head handling cannot be the reason of this breakage in a normal use.An excessive tightening of the 3 screws of the interface assembly cannot lead to such a breakage neither.According to the report (b)(4), the recommended cleaning products involving a chemical reaction and thus the interface weakness is ruled out, which cannot be confirmed with prohibited products.Therefore, the most probable root cause of this breakage could be then a combination of chemical stress and excessive radial force applied on the handle.For that reason, based on satisfactory feedback from the field about a similar part on pwd500 the modification 180614 was engaged with the new supplier replacing the row material abs+pc by pa66.In february 2019, mechanical and chemical tests were performed to validate this change.The report (b)(4) mentions the conformity of these parts made in pa66.New parts in pa66 have been launched in production in may 2019 and all interfaces stamped with the date of 2019 or after belong to the latest version.Regarding this case the interface is prior 2019, hence belongs to the previous version (abspc).It should be noted that this part is also used for volista triop and axcel range lights.Any similar breakage would have the same root cause described above.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: POWERLED TM
• 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: 20179574
• Report Number: 9710055-2024-00506
• Device Sequence Number: 8931247
• Product Code: FSY
• UDI-Device Identifier: 03700712405977
• UDI-Public: (01)03700712405977
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/10/2024

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: ARD268300170A
• Device Catalogue Number: PWD30+DF XS32 K3 SPE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown