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

Model Number ARD568330931

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our surgical light - powerled.As it was stated plastic ring which holds the adapter was cracked.Photographic evidence was in line with alleged issue and revealed that due to this crack some particles were missing.No information about injury was provided however we decided to report this case in abundance of caution and based on potential as any parts falling into sterile field might be a source of contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light - powerled.As it was stated the plastic ring, which holds the adapter, was found to be cracked.Photographic evidence was in line with the alleged issue and revealed that due to this crack some particles were missing.No information about injury was provided, however, we decided to report this case in abundance of caution and based on potential as any parts falling into sterile field might be a source of contamination.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.The light head pwd 300 is conforming to the standard iec 60601-2-41 and therefore the light head handling cannot be the reason of such 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 180614 was engaged with the new supplier replacing the row material abs+pc by pa66.In (b)(6)2019 mechanical and chemical tests were performed to validate this change.The report re 19-010 mentions the conformity of these parts made in pa66.New parts on pa66 have been launched in production in (b)(6)2019.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.

Event Description

Manufacturer reference number 354357.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 10539423
• MDR Text Key: 207105684
• Report Number: 9710055-2020-00368
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568330931
• Device Catalogue Number: ARD568330931
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1