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

Model Number ARD569202911

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter was medical technology.Event site name: (b)(6).Event site telephone: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On (b)(3) 2023 getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the control panel of the light is completely non-functional.Designated complaint unit employee confirmed based on photographic evidence the paint was peeling from handle.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 18th october, 2023 getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the control panel of the light is completely non-functional.Designated complaint unit employee confirmed based on photographic evidence the paint was peeling from handle.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 18th october, 2023 getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the control panel of the light is completely non-functional.Designated complaint unit employee confirmed based on photographic evidence the paint was peeling from handle.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 20th december 2023 indicated the devon handle is not painted, it is made of aluminum, so there is no risk of any particles falling from the handle.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Initial information provided was pointing that the paint was peeling from handle.Paint peeling based on risk, is considered as a potentially reportable incident, therefore an incident was reported.After after receiving emial from getinge employee informed that the devon handle is not painted, it is made of aluminum.Therefore the initial information that were considered to be reportable was determined to did not occur.We have performed a root cause evaluation for the handle issue.The investigated customer product complaint did not cause risk to human life.When the issue occurs, the device is not up to the manufacturer specification, usually after replacement of the component the device could return to normal use.If the device is used in accordance with instruction provided in user manual, such as regular preventive maintenance any unexpected failures should not occur.After reviewing the information provided for the complaints investigated herein we have been able to establish that there is no significant complaint trend with this product and issue type.Complaint handler did not identify any apparent reason for suggesting to open a capa (apart from these already initiated) or evaluation for the need of another action in the market.It is not likely that it could lead to the serious injury or death when the malfunction reoccurs.

Event Description

On 18th october, 2023 getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the control panel of the light is completely non-functional.Designated complaint unit employee confirmed based on photographic evidence the paint was peeling from handle.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 20th december 2023 indicated the devon handle is not painted, it is made of aluminum, so there is no risk of any particles falling from the handle.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• 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: 18334272
• MDR Text Key: 330593916
• Report Number: 9710055-2023-00962
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569202911
• Device Catalogue Number: ARD569202911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1