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

Model Number ARDLCA309008A

Device Problems Corroded (1131); Failure to Clean Adequately (4048)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

On 7th july, 2023 getinge became aware of an issue with one of surgical lights - prismalix.It was stated the corrosion has built up on the spring arm as a result of cleaning fluid ingress.We decided to report the issue in abundance of caution as any rust particles or fluid falling off into sterile field or during procedure may cause contamination and contact of water with live parts may cause electric shock.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - prismalix.It was stated the corrosion has built up on the spring arm as a result of cleaning fluid ingress.We decided to report the issue in abundance of caution as any rust particles or fluid falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to rust such a scenario could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does indicate that upon the event occurrence, the device was not being used for patient treatment.When reviewing similar reportable events for the same device type, over the last 5 years, there was no serious injury or worse reported.We can assume that the failure ratio of rust on prismalix devices is very low.A technical evaluation of rust was performed by subject matter experts who stated that: 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 environnemental condition for use, the relative humidity must be between 20% and 75%.(prismalix user manual 0113103 ed3g, page 9) 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.(prismalix user manual 0113103 ed3g, page 28).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.Initial reporter: getinge service technician.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 7th july, 2023 getinge became aware of an issue with one of surgical lights - prismalix.It was stated the corrosion has built up on the spring arm as a result of cleaning fluid ingress.We decided to report the issue in abundance of caution as any rust particles or fluid falling off into sterile field or during procedure may cause contamination and contact of water with live parts may cause electric shock.Corrected b5 describe event or problem: on 7th july, 2023 getinge became aware of an issue with one of surgical lights - prismalix.It was stated the corrosion has built up on the spring arm as a result of cleaning fluid ingress.We decided to report the issue in abundance of caution as any rust particles or fluid falling off into sterile field or during procedure may cause contamination.

Event Description

On 7th july, 2023 getinge became aware of an issue with one of surgical lights - prismalix.It was stated the corrosion has built up on the spring arm as a result of cleaning fluid ingress.We decided to report the issue in abundance of caution as any rust particles or fluid falling off into sterile field or during procedure may cause contamination.

• Brand Name: PRISMALIX
• 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: 17669457
• MDR Text Key: 322478677
• Report Number: 9710055-2023-00615
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA309008A
• Device Catalogue Number: ARDLCA309008A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1