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

Model Number ARD568410110C

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the dust cover was disintegrating.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.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event and problem and d4 catalog # and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 12th july, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the dust cover was disintegrating.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.Corrected b5 describe event and problem: on 12th july, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the dust cover was disintegrating.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.Further information provided by getinge technician indicated that the lexan protection cover was ripped but no particles were missing and nothing fell down.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous d4 catalog # ard568410110c.Corrected d4 catalog # ard568350930/ard568350931.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 initially provided information was pointing that the dust cover was disintegrating.The issue was considered as safety related as any particles falling off into sterile field or during procedure may cause contamination.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 particles missing on this device.Therefore, the scenario described in the record is considered as non-reportable.

Event Description

On 12th july, 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated the dust cover was disintegrating.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.Further information provided by getinge technician indicated that the lexan protection cover was ripped but no particles were missing and nothing fell down.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 missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: POWERLED
• Type of Device: 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: 17403286
• MDR Text Key: 319844283
• Report Number: 9710055-2023-00550
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/27/2023

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 Operator: Health Professional
• Device Model Number: ARD568410110C
• Device Catalogue Number: ARD568350930/ARD568350931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1