MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number ARD569201917

Device Problem Device Handling Problem (3265)

Patient Problem Skin Tears (2516)

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 ii.As it was stated, when the nurse raised the monitor arm vertically her hand was placed under the dust cover that covers the connection of the spring arm and the monitor holder, the hand was pinched between the metal dust cover and the spring arm cover, in result the thumb has been cut.Medical intervention was not required, the device involved in the event was inspected and it was confirmed there was no fault found.We decided to report the issue in abundance of caution as pinch of hand may lead to serious injury.

Event Description

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

Manufacturer Narrative

Getinge became aware of an incident with one of surgical lights - powerled ii.As it was stated, when the nurse raised the monitor arm vertically her hand was placed under the dust cover that covers the connection of the spring arm and the monitor holder.Her hand was pinched between the metal dust cover and the spring arm cover, in result of the pinch she received a cut on her thumb.Medical intervention was not required, however we decided to report the issue based on the received information that cut was sustained and our initial evaluation that this kind of issue could potentially lead to the serious injury.In the course of the investigation and review of the risk analysis file it was established that such case should not be considered as safety related and reportable, as it did not lead to the serious injury and it is not likely it would during reoccurrence.The device involved in the event was inspected and it was confirmed no fault of the device was found.It was established that when the event occurred, the surgical lamp did meet its specification, although no malfunction was found the device contributed to the event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.When reviewing reportable events for the same device type, we have been able to confirm that the investigated issue is the first with provided allegation and that device did not contribute to the serious injury as no medical intervention was required.The subject matter experts at the manufacturing site have investigated this type of issue and concluded as follows: according to the explanations, provided no defects were found and no sharp edges found on the device.This incident is clearly due to a misuse.Actually, the user's hand does not have to be placed at this location of the device.As it is written in the incident report, it seems that the proper handle was not used for monitor positioning.To prevent any similar incident, it is recommended to use proper handle for monitor positioning.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of h4 manufacture date field deems required.This is based on the internal evaluation.Previous h4 manufacture date 2nd december 2020 corrected h4 manufacture date 28th may 2021.

• Brand Name: POWERLED II
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12195302
• MDR Text Key: 262439558
• Report Number: 9710055-2021-00248
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569201917
• Device Catalogue Number: ARD569201917
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other