MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number ARDLCA209012A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On 18th july, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury in case of event reoccurrence.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event or problem and h6 component codes fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 18th july, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury in case of event reoccurrence.Corrected b5 describe event or problem: on 18th july, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, spring arm cap was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury in case of event reoccurrence.Previous h6 component codes: mechanical|cover||772.Corrected h6 component codes: mechanical|cap||424.

Event Description

On 18th july, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, spring arm cap was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury in case of event reoccurrence.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, spring arm cap was missing.There was no injury reported, however, we decided to report the issue in an abundance of caution as any parts falling off into a sterile field or during a procedure may cause contamination or serious injury in case of event reoccurrence.According to the information provided in the record, the getinge technician sent a quote for a cap replacement.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the missing cap could be considered a technical deficiency, and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by the subject matter expert, the most probable root cause of the break of this cap is repeated and violent shocks during the use of the device.Another probable root cause is that the cap has been forgotten or deteriorated after a re-adjustment of the spring arm during the maintenance of a medical device.The yearly preventive maintenance program documented in the technical manuals mentions to check the presence and fixing of the plastic covers.The cap must be reinstalled during installation or after the maintenance procedure.Maquet sas strongly advises to check similar devices present at the customer site in order to check the presence of all spring arms caps.If a missing cap is noticed, a new one should be ordered as spare parts (reference: (b)(4)).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: LUCEA 50
• Type of Device: LAMP, SURGICAL
• 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: 15062322
• MDR Text Key: 304538071
• Report Number: 9710055-2022-00280
• Device Sequence Number: 1
• Product Code: FTD
• UDI-Device Identifier: 3700712400637
• UDI-Public: (01)3700712400637
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA209012A
• Device Catalogue Number: ARDLCA209012A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1