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

Model Number	ARD568420710A
Medical Device Problem Codes	Corroded (1131); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 4th may 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 500/300.As it was stated, the corrosion has built up on the device.Additionally, according to photographic evidence, paint was peeling from the fork and label was damaged with missing particles.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.
Additional Manufacturer Narrative
Initial reporter: getinge service technician the correction of b5 describe event and problem and d4 version of model # and h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th may 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 500/300.As it was stated, the corrosion has built up on the device.Additionally, according to photographic evidence, paint was peeling from the fork and label was damaged with missing particles.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 4th may 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 500/300.As it was stated, the corrosion has built up on suspension arm of the device and screws and dust covers were missing.Additionally, according to the photographic evidence, paint was peeling from the fork and suspension arm, and label was damaged with missing particles.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.Previous d4 version of model # ard568350933/ard568330933.Corrected d4 version of model # ard568420710a.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of our surgical lights ¿ powerled 500/300.As it was stated, the corrosion has built up on suspension arm of the device and screws and dust covers were missing.Additionally, according to the photographic evidence, paint was peeling from the fork and suspension arm, and label was damaged with missing particles.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.It was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.The photographic evidences show rust formation and paint peeling on the device.It can be observed that the degradation of the paint and corrosion are mostly localized on the retention areas which shows that the stagnation of liquid or cleaning agent residues have caused paint damages and appearance of rust.Peeling paint and rust formation were probably caused by : - a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol, - the presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75%.To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages.The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.To reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manual mentions in the preventive maintenance protocol to lubricate some parts of device.The instruction for use mentions not to use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.Label peeling is probably due to collision or repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.The user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks.The possible root causes are : - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device) maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.It was detected loose screws on the spring arm cover.These screws attach the covers on the spring arm structure.The manufacturer of the spring arms, ¿ondal¿, led several tests on a spring arm performing 20.000 cycles of up and down movement.The test with a loosen screw, with a complete turn back, shows that it¿s the only case where the screw continue to loosen.Based on the analysis of the cases reported, several cases were detected, all delivered in the same hospital, on a period less than 1 year after the installation, the other cases were detected more than 1 year after the installation.The cases detected after more than 1 year after the installation correspond to a lack of inspection during the yearly preventive maintenance.The loosening detected on a period less than 1 year after the installation probably corresponds to a manufacturing issue, due to an incorrect initial tightening on the production line.To prevent the loosening and the fall of the screw, the technical manuals indicate to check all the fixing screws and to check the hold of the spring arm covers during yearly preventive maintenance.The screw have a long threading, its loosening is visually detectable during cleaning or during yearly preventive maintenance.As improvement measure, since october 2019, the spring arms covers are assembled, on the product line, with tuflok coated screws.In any case, by design, the nylon patch of these screws acts as a mechanical locking and prevents the loosening and the fall of the screw.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
On 4th may 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 500/300.As it was stated, the corrosion has built up on suspension arm of the device and screws and dust covers were missing.Additionally, according to the photographic evidence, paint was peeling from the fork and suspension arm, and label was damaged with missing particles.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.

• Brand Name: POWERLED
• Common Device Name: 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: 16886458
• Report Number: 9710055-2023-00335
• Device Sequence Number: 6174236
• Product Code: FSY
• UDI-Device Identifier: 03700712403089
• UDI-Public: (01)03700712403089
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Model Number: ARD568420710A
• Device Catalogue Number: ARD568350933/ARD568330933
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown