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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568410710A
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
 
Event Description
On 17th january, 2021 getinge became aware of an issue with powerled surgical light.As it was stated, the handle ring was broken.Photographic evidence shows that particles are missing.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
On 17th january, 2021 getinge became aware of an issue with powerled surgical light.As it was stated, the handle ring was broken.Photographic evidence shows that particles are missing.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.The configuration involved in the event is: powerled 500+ df k3 (catalog number ard568350933, serial number (b)(6)); powerled 300+ df k3 (catalog number ard568330933, serial number (b)(6)).Manufacturing date is 2nd september 2015.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.Per the investigation by subject matter experts at the manufacturing site 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).We believe that the devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.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 correction of d4 version or model # and catalog # deem required.This is based on the internal analysis.Previous d4: version or model # ard568410710a; catalog # ard568410710a.Corrected d4: version or model # ard568350933; catalog # ard568350933.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
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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 Key11228455
MDR Text Key228636104
Report Number9710055-2021-00026
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARD568410710A
Device Catalogue NumberARD568410710A
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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