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

Model Number ARD568331999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated retaining ring of the handle was missing.No further information was provided, however we decided to the report this case in abundance of caution as missing retaining ring on the handle could cause detachment of the component and this further could led to contamination.

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

On 9th february, 2021 getinge became aware of an issue with powerled surgical light.As it was stated, plastic ring (localized around sterilizable handle holder) cracked and the customer removed afterwards.There was no injury reported, however, we decided to report the event in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.The device involved in the event is powerled 300 with serial number ar040234 and catalog number ard568331999.The device was manufactured on 13th december 2010.It was established that when the event occurred, the surgical light did not meet its specification as breakage of the mounting ring could be identified as a technical deficiency.The device which played role in this situation contributed to event.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.As it was established by the subject matter expert from the manufacturing site that the light head pwd300 is conforming to the standard iec 60601-2-41 and therefore the light head handling cannot be the reason of this breakage in a normal use.An excessive tightening of the 3 screws of the interface assembly cannot lead to such a breakage neither.According to the internal testing the recommended cleaning products involving a chemical reaction and thus the interface weakness is ruled out, which cannot be confirmed with prohibited products.In the course of our investigation, the most likely root cause of the breakage is considered to be a combination of chemical stress and excessive radial force applied on the handle.For that reason, based on satisfactory feedback from the field about a similar part on pwd500 the modification was engaged with the new supplier replacing the row material abs+pc by pa66.In february 2019 mechanical and chemical tests were performed to validate this change.The report mentions the conformity of these parts made in pa66.New parts on pa66 have been launched in production in may 2019 and all interfaces stamped with the date of 2019 or after belong to the latest version.Regarding this case the interface is prior 2019, hence belongs to the previous version (abspc).It should be noted that this part is also used for volista triop and axcel range lights.Any similar breakage would have the same root cause described above.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The purpose of this submission is also to provide a correction of describe event or problem #b5.This is based on internal evaluation of available data.#b5 previous describe event or problem: on 9th of february 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated retaining ring of the handle was missing.No further information was provided, however we decided to the report this case in abundance of caution as missing retaining ring on the handle could cause detachment of the component and this further could led to contamination.Corrected describe event or problem: on 9th of february 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated retaining ring of the handle was missing.We decided to the report this case in abundance of caution as missing retaining ring on the handle could cause detachment of the component and this further could led to contamination.On 17th of february, 2021 we received information that repair request of plastic ring (localized around sterilizable handle holder) was made while the getinge service technician was performing a visit on different device (operating table).The technician explained that the ring was removed by the facility staff after it broke and there was no missing parts or particles.

Event Description

On 9th of february 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated retaining ring of the handle was missing.We decided to the report this case in abundance of caution as missing retaining ring on the handle could cause detachment of the component and this further could led to contamination.On 17th of february, 2021 we received information that repair request of plastic ring (localized around sterilizable handle holder) was made while the getinge service technician was performing a visit on different device (operating table).The technician explained that the ring was removed by the facility staff after it broke and there was no missing parts or particles.Manufacturer reference number (b)(4).

• 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
• MDR Report Key: 11321452
• MDR Text Key: 231614189
• Report Number: 9710055-2021-00059
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568331999
• Device Catalogue Number: ARD568331999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1