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

Model Number ARD568330951

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

On 1st february, 2024 getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the headlight handle ring was cracked and partially detached.The issue was discovered during preventive maintenance.As technician stated, no parts have fallen down and no parts were 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 in case of reoccurrence.

Manufacturer Narrative

Event site name : (b)(6).Event site telephone: (b)(6).Event site postal code:(b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event and problem, h3a device evaluated by manufacturer, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the headlight handle ring was cracked and partially detached.The issue was discovered during preventive maintenance.As technician stated, no parts have fallen down and no parts were 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 in case of reoccurrence.Corrected b5 describe event and problem: on (b)(6) 2024 getinge became aware of an issue with one of surgical lights - hled 300.It was stated and also confirmed by photographic evidence that headlight handle ring was cracked and partially detached.As technician stated, no parts have fallen down and no parts were 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 in case of reoccurrence.Previous h3a device evaluated by manufacturer?: no.Corrected h3a device evaluated by manufacturer?: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: blank.Previous h3c if other provide code -explain: device not returned to manufacturer.Corrected h3c if other provide code -explain: blank.Getinge became aware of an issue with one of surgical lights - hled 300.It was stated and also confirmed by photographic evidence that headlight handle ring was cracked and partially detached.As technician stated, no parts have fallen down and no parts were 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 in case of reoccurrence.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since handle cracked/ detached with missing particles could be considered as technical deficiency, and in this way the device contributed to the event.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered during daily check.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue handle cracked/ detached with missing particles on powerled and hled surgical lights, there were no events which led to the serious injury.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio is low.A root cause analysis for the issue of broken handle rings was performed by the manufacturer¿s subject matter experts (sme) and according to their analysis; 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 normal use.An excessive tightening of the 3 screws of the interface assembly cannot lead to such a breakage neither.According to an investigation by the sme at the manufacturer, the recommended cleaning products involving a chemical reaction and thus the interface weakness is ruled out, which cannot be confirmed with prohibited products.Therefore, the most probable root cause of this breakage could be then 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 sme¿s report mentions the conformity of these parts made in pa66.New parts in pa66 have been launched in production in (b)(6) 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.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - hled 300.It was stated and also confirmed by photographic evidence that headlight handle ring was cracked and partially detached.As technician stated, no parts have fallen down and no parts were 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 in case of reoccurrence.

• Brand Name: HLED
• 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: 18639036
• MDR Text Key: 334502575
• Report Number: 9710055-2024-00122
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: ARD568330951
• Device Catalogue Number: ARD568330951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1