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

Model Number ARDPWT259154A

Device Problems Peeled/Delaminated (1454); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 16th october, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence that paint was chipping from suspension tube.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

Event Description

On 16th october, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence that paint was chipping from suspension tube.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that the issue was discovered after the shipment and before handover to the customer.According to this information, the issue should be considered as not safety and risk related.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The correction of b5 describe event and problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 16th october, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence that paint was chipping from suspension tube.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 16th october, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence that paint was chipping from suspension tube.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that the issue was discovered after the shipment and before handover to the customer.According to this information, the issue should be considered as not safety and risk related.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|degraded|peeled/delaminated 1454.Corrected h6 medical device ¿ problem code: no apparent adverse event 3189.Initially provided information was pointing to paint chipping from suspension tube.The issue was considered as safety related as any parts falling off into sterile field or during procedure may cause serious injury.According to additional clarification provided by the getinge technician, the initial information wasn't clear.It was determined that the issue investigated herein is not safety and risk related as the issue was discovered after the shipment but before handover to the customer.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: POWERLED II
• Type of Device: 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: 18139085
• MDR Text Key: 328148354
• Report Number: 9710055-2023-00882
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDPWT259154A
• Device Catalogue Number: ARD567201353
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1