MAUDE Adverse Event Report: MAQUET SAS MAQUET POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT209057A
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
Additional Manufacturer Narrative
Initial reporter was clinical engineer.(b)(6).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) 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the tube rubber came off and satellite cover fell down.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.
Event or Problem Description
On 9th january, 2024, getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the tube rubber cap came off and satellite cover fell down.It was confirmed by photographic evidence the satelite- ceiling cover seal came off and the cover fell down.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 cover couldn't fall to the floor, as it would be caught on the horizontal arm.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 the cover falling to sterile field, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d1 brand name, d4 catalog#, d4 unique identifier#, h3a device evaluated by mfg, h3b device not eval provide code, h3c if other provide code-explain, h6 investigation findings and h6 investigation conclusions deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 9th january 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the tube rubber came off and satellite cover fell down.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 9th january 2024 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the tube rubber cap came off and satellite cover fell down.It was confirmed by photographic evidence the satelite- ceiling cover seal came off and the cover fell down.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 cover couldn't fall to the floor, as it would be caught on the horizontal arm.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 the cover falling to sterile field, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous d4 catalog# unknown.Corrected d4 catalog# none.Previous d4 unique identifier (udi)#: n/a.Corrected d4 unique identifier (udi): (b)(4).Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: none.Previous h3c if other provide code-explain: device not returned to manufacturer.Corrected h3c if other provide code-explain: none.Previous h6 investigation findings: results pending completion of investigation|||3233.Corrected h6 investigation findings: none.Previous h6 investigation.Conclusions: conclusion not yet available||11.Corrected h6 investigation conclusions: cause not established||4315.Initially provided information was pointing to cover detachment.The issue was 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 the cover falling to sterile field, which was initially considered, as it would be caught on the horizontal arm.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.

• Brand Name: MAQUET POWERLED II
• Common Device Name: LAMP, 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: 18490878
• Report Number: 9710055-2024-00029
• Device Sequence Number: 7056719
• Product Code: FTD
• UDI-Device Identifier: 03700712407674
• UDI-Public: (01)03700712407674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/11/2024

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: ARDPWT209057A
• Device Catalogue Number: ARDPWT209057A
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown