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

Model Number ARD568370900

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6)2022 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.According to photographic evidence, an underside cover was cracked and particles were missing.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.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ powerled 700.According to photographic evidence, an underside cover was cracked and particles were missing.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.According to the information provided by getinge technician, the affected underside cover ((b)(6) - pwd700 - kit sousface) was replaced.It was established that when the event occurred, the surgical light did not meet its specification due to cracked underside cover, which led to missing particles and as a result contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of missing particles from the underside cover is low.As stated by subject matter expert at manufacturing site, all maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ disinfection products test: maquet sas described how to perform the material resistance test in the working instruction ref.Fl 007.The following disinfection products are tested: surfa¿safe, isopropyl alcohol, incidin pro, virkon.The aim of these tests is to detect any incompatibility with disinfectant.As per subject matter expert¿s expertise, the involved zone was probably exposed to collisions and the edges damaged correspond to a retention zone.These facts indicate that cleaning agent residues may have a negative reaction on plastic surfaces and lead to its degradation.The concentration of chemical products, the stagnation of substance residues on the surfaces are probably the main factors leading to the deterioration of surfaces.To avoid paint degradation and corrosion it is recommended to respect the contact time of cleaning agent with the device and to wipe it with a dry cloth and to make sure no liquid residue is left on the device after cleaning (powerled ifu 01581 en09, pages 35-36).User manual for powerled (ifu 01581 en09, pages 20-22) also mentions to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.To prevent similar incidents, it is recommended to respect the cleaning instructions and avoid: ¿ prolonged exposure to detergents and disinfectants solutions ¿ high concentrations of cleaning agents ¿ prohibited products we believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• 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: 16066539
• MDR Text Key: 306409481
• Report Number: 9710055-2022-00562
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568370900
• Device Catalogue Number: ARD568370900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1