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

Model Number ARD568303902

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with h-led surgical light.As it was stated, the elbow was unscrewed.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Event Description

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

Manufacturer Narrative

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

Event Description

On 24th february, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the elbow was unscrewed.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Afterwards, the photographic evidences of the malfunction were provided and revealed that the affected device is a type of the surgical light with an incorporated camera option and the part that was alleged to be unscrew was in fact a detached bumper.With such design, the cables from the camera passes through the inside of the bumper, so even when the bumper is unhooked, there is no risk of it falling into the sterile field, because this part will hang on the cables.As a result, this ultimately proved to be a non-safety related issue.

Manufacturer Narrative

Getinge became aware of an issue with hled surgical light.As it was stated, the elbow was unscrewed.At the time of receiving the information, there was no suggestion of injury reported however we decided to report the issue in abundance of caution as loose components may create a risk of parts falling off into sterile field or during procedure may cause contamination.Afterwards, the photographic evidences of the malfunction were provided and revealed that the affected device is type of the surgical light with an incorporated camera option and the part that was alleged to be unscrewed was in fact a detached bumper.Per the design, those passes through the inside of the bumper, therefore event if the bumper gets unhooked, it will still remain connected to the device and would not create risk of falling parts.During the investigation, and review of the risk analysis file it was established that such case is not safety related, did not lead do serious injury and during reoccurrence, it is not likely to lead to serious injury or worse.It was established that when the event occurred, the device did not meet its specification, due to a loose bumper on the device and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.When reviewing customer product complaints for this type of issues we were able to establish that the received incident is occurring at a very low ratio for the same device type.The loose bumper is due to repeated collisions or a partial repositioning.Tests performed show that the bumper can fall after several violent collisions with the cupolas.This corresponds to an abnormal use.However, in specific cases, especially when the ceiling is lower (as for single fork configuration) it can happen that a cupola light hits the bumper during manipulation with a specific angle.For this reason, manufacturer recommends to secure the bumpers with screws as specified in the documentation ni 01584/01814 for every single fork configuration.To prevent any similar incident manufacturer recommends: 1.To avoid collision.2.To check the correct positioning of the cover after maintenance or cleaning.3.To secure the bumpers with screws.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Correction of field #b5 describe event or problem.It is required.This is based on internal evaluation.Previous: on 24th february, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the elbow was unscrewed.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Corrected: on 24th february, 2021 getinge became aware of an issue with hled surgical light.As it was stated, the elbow was unscrewed.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Afterwards, the photographic evidences of the malfunction were provided and revealed that the affected device is a type of the surgical light with an incorporated camera option and the part that was alleged to be unscrew was in fact a detached bumper.With such design, the cables from the camera passes through the inside of the bumper, so even when the bumper is unhooked, there is no risk of it falling into the sterile field, because this part will hang on the cables.As a result, this ultimately proved to be a non-safety related issue.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11385585
• MDR Text Key: 233775914
• Report Number: 9710055-2021-00080
• Device Sequence Number: 1
• Product Code: FSY
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568303902
• Device Catalogue Number: ARD568303902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1