MAUDE Adverse Event Report: MAQUET SAS LUCEA 10/40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Catalog Number ARD568601999

Device Problems Crack (1135); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 9th november 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the handle of the lucea 40 ceiling suspension was broken with missing particles and light has fallen during surgery.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

On 9th november 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was initially stated, light has fallen during surgery.After checking the details, it turned out that the light didn't fall down, but the cover at the headlight mounting was broken and the small white particles fell on the patient.The issue was confirmed by photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 9th november 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was stated the handle of the lucea 40 ceiling suspension was broken with missing particles and light has fallen during surgery.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 9th november 2022, getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was initially stated, light has fallen during surgery.After checking the details, it turned out that the light didn't fall down, but the cover at the headlight mounting was broken and the small white particles fell on the patient.The issue was confirmed by photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.Getinge became aware of an issue with one of our examination lights ¿ lucea 40.As it was initially stated, light has fallen during surgery.After checking the details, it turned out that the light didn't fall down, but the cover at the headlight mounting was broken and the small white particles fell on the patient.The issue was confirmed by photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.Based on the information collected, it was established that when the event occurred, the examinational light did not meet its specification, due to headlight cracked with missing particles, which could be considered as technical deficiency, and in this way the device contributed to the event.Based on an information gathered, the device was being used for patient treatment when the event occurrence.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of headlight cracked with missing particles, there is no event which led to the serious injury.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio for the issue of cracked headlight with missing particles is moderate.As stated by subject matter expert at the manufacturing site, the headlight is cracked due to a violent rotation of the light head.It can be noticed that the housing is split at the stop location.This stop is used to limit the rotation of the light to 290°.The insertion of the stop in the housing (made of abs-pc) is performed by ultrasonic process.It means that it is strain-free after assembly.Then, the only possible root cause to split the housing at this location is a violent shock during rotation.Regarding this stop rotation some tests have been done in 2011 at maquet sas.The test report re11-052 mentions that the light lucea 40 is compliant to the standard ul60601-1.Indeed, tests have been performed on 2 light heads with 50 strong rotations on both direction (clockwise and counterclockwise) and no cracks were found.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 10/40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 15796880
• MDR Text Key: 303736236
• Report Number: 9710055-2022-00471
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568601999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1