MAUDE Adverse Event Report: MAQUET SAS LUCEA; LAMP, SURGICAL

Model Number ARDLCA309006A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.

Event Description

On 14th may, 2019 getinge became aware of an issue with one of our devices ¿ lucea.As it was stated the lamp had cracks on cover which led to missing plastic particles.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as any particles transferred into sterile field might be a source of contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On 14th may, 2019 getinge became aware of an issue with one of our devices ¿ lucea.As it was stated the lamp had cracks on cover which led to missing plastic particles.No injury has been reported due to mentioned issue however we decided to report it based on the potential as any particles transferred into sterile field might be a source of contamination.The device involved in the event is lucea 100 (tub 1200-65) with serial number (b)(6) and catalog number ard569070999.Manufacturing date is 27th of august 2018.It was established that when the event occurred, the surgical light did not meet its specification due to the damaged cover leading to missing plastic particles and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have reviewed the issue and unfortunately, despite the effort made in gathering more detailed information, the specific root cause wasn¿t possible to be established.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of additional manufacturer narrative/corrected data section (h10) and event problem and evaluation codes (h6).This is based on the result of an internal review.#h6: evaluation result codes- previous: no findings avialable (3221) evaluation result codes- corrected: maintnance problem (115) evaluation conclusion codes- previous: cause not established (4315) evaluation conclusion codes- corected: cause traced to maintenance (51) #h10: previous: on 14th may, 2019 getinge became aware of an issue with one of our devices ¿ lucea.As it was stated the lamp had cracks on cover which led to missing plastic particles.No injury has been reported due to mentioned issue however we decided to report it based on the potential as any particles transferred into sterile field might be a source of contamination.The device involved in the event is lucea 100 (tub 1200-65) with serial number (b)(6) and catalog number ard569070999.Manufacturing date is 27th of august 2018.It was established that when the event occurred, the surgical light did not meet its specification due to the damaged cover leading to missing plastic particles and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have reviewed the issue and unfortunately, despite the effort made in gathering more detailed information, the specific root cause wasn¿t possible to be established.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Corrected: on 14th may, 2019 getinge became aware of an issue with a surgical light lucea100.As it was stated, the plastic cover was cracked which resulted in missing particles.There was no injury reported however we decided to report the issue based on the potential as any parts or particles falling off may lead to the surgical field contamination.Device involved in the event has catalog number ard569070999 and serial number (b)(6) manufacturing date is 27th of august 2018.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to described event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.The review of complaints closed with the root cause ¿impossible to define¿ was made with the manufacturer.The manufacturer concluded that in (b)(4) from reviewed complaints the root cause is to be updated as it was confirmed by subject matter experts from the manufacturing site the most likely root cause of the situation occurrence is related to the combination of different factors: mechanical stress, use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.For cleaning, the ifu informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.However the test performed showed that the aggressive cleaning agents can lead to the situation under this investigation only in combination with a mechanical stress.Cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.We believe that devices in the market are performing correctly overall.We also find the issue as highly detectable during daily visual inspection which is an important step given in the user manual.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10379098
• MDR Text Key: 202058530
• Report Number: 9710055-2020-00285
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA309006A
• Device Catalogue Number: ARDLCA309006A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1