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

Catalog Number ARD568350931

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6), 2021 getinge became aware of an issue with one of surgical lights - powerled.Bolt inside cupola was found sheared.This bolt is responsible for holding the headlight.There was no injury reported in relation to this particular situation however we decided to report based on the potential related to headlight detachment and its possible serious consequences, if the situation was to reocurr.

Event Description

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

Manufacturer Narrative

Additional information will be provided upon results of investigation.The purpose of this submission is provide a correction of catalog#.This is based on the result of an internal review noting the report did not contain available information.#d4 previous #catalog: ard568422010c.Corrected #catalog: ard568350931.

Event Description

On 22nd december, 2021 getinge became aware of an issue with one of surgical lights - powerled.Screw inside cupola was found sheared.This screw is responsible for holding the headlight.There was no injury reported in relation to this particular situation, however we decided to report based on the potential related to headlight detachment and its possible serious consequences, if the situation was to reoccur.

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 22nd december, 2021 getinge became aware of an issue with one of surgical lights - powerled.Bolt inside cupola was found sheared.This bolt is responsible for holding the headlight.There was no injury reported in relation to this particular situation however we decided to report based on the potential related to headlight detachment and its possible serious consequences, if the situation was to reocurr.Corrected b5 describe event and problem: on 22nd december, 2021 getinge became aware of an issue with one of surgical lights - powerled.Screw inside cupola was found sheared.This screw is responsible for holding the headlight.There was no injury reported in relation to this particular situation, however we decided to report based on the potential related to headlight detachment and its possible serious consequences, if the situation was to reoccur.Getinge became aware of an issue with one of surgical lights - powerled.Screw inside cupola was found sheared.This screw is responsible for holding the headlight.There was no injury reported in relation to this particular situation, however we decided to report based on the potential related to headlight detachment and its possible serious consequences, if the situation was to reoccur.According to the information provided by getinge technician, customer had replaced sheared screw on his own.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification, since sheared screw connecting frame with the beam could be considered as technical deficiency, and in this way the device contributed to the event.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 issues we were able to establish that the received incidents are occurring at very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As per expertise performed by the subject matter expert at manufacturing site, it was reported that a screw, that connect the beam to the frame, sheared off.Three screws enable the mechanical connection between the beam and the frame.According to the photographic evidences, the beam was partially detached from the frame showing a detectable large opening and a screw was still connected to the frame.A progressive loosening of a screw or an excessive effort applied on the light head probably led to the rupture of the screw.To prevent the loosening and then rupture of the screws, the production assembly procedure "gom 5344" indicates to use loctite 243 threadlocker on the 3 fixing screws.This procedure was initially issued in 2011, while the affected device was manufactured in 2013.Therefore, the aforementioned scenario can be ruled out.The powerled instruction for use (ifu 01581 en 09) on page 20 mentions to check the integrity of the device performing, by trained personnel, daily visual and functional inspections to ensure that the product used is compliant.In the case investigated herein, based on the information gathered, the most probable root cause is user error.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer 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: 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: 13091901
• MDR Text Key: 282819145
• Report Number: 9710055-2021-00384
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568350931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1