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

Model Number ARD568350910

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

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

On 19th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the handle on the light head was broken.Designated complaint unit employee confirmed based on photographic evidence that headlight handle was broken and tape was used to secure it.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.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site postal code: (b)(6).H3 other text : device not returned to manufacturer.

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 19th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the handle on the light head was broken.Designated complaint unit employee confirmed based on photographic evidence that headlight handle was broken and tape was used to secure it.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.Corrected b5 describe event and problem: on 19th december 2023 getinge became aware of an issue with one of the surgical lights - powerled 500.It was stated the handle on the light head was broken.During our evaluation this was confirmed based on photographic evidence - the headlight handle was broken, and tape was used to secure it.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.Getinge became aware of an issue with one of the surgical lights - powerled 500.It was stated the handle on the light head was broken.During our evaluation this was confirmed based on photographic evidence - the headlight handle was broken, and tape was used to secure it.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.Based on the information gathered, it appears the defective set cover with ext.Handle pwd700/evo (ard368321998) was replaced, and device is back in usage.It was established that when the event occurred, the surgical light did not meet its specification due to handle on the light head having been broken, which contributed to the event.It is unknown if the device was or was not being used for a patient¿s treatment upon the event¿s occurrence.The review of received customer product complaints related to the investigated issues revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio for handle breakage is low.A technical evaluation of root cause for the headlight handle breakage was performed by subject matter experts at the manufacturing site.As factory investigation review stated, the product must be repaired before any use.Only abnormal use (violent collisions, excessive pressure¿) can damage this device as reported in this complaint.The user manual explains how to check the light heads during daily inspection.(attachment 2 ¿ user manual ifu_01581_en 2020-04-01_extract, pages 20-22).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 19th december 2023 getinge became aware of an issue with one of the surgical lights - powerled 500.It was stated the handle on the light head was broken.During our evaluation this was confirmed based on photographic evidence - the headlight handle was broken, and tape was used to secure it.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.

• Brand Name: POWERLED
• 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: 18408286
• MDR Text Key: 331491698
• Report Number: 9710055-2023-00987
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568350910
• Device Catalogue Number: ARD568350910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1