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

Model Number ARD569202915

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 11th august, 2020 getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, caps and screws on spring arm were loose.There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, caps and screws on spring arm were loose.There was no injury reported however we decided to report the issue basing on potential as any parts falling off into sterile field or during procedure may be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification as the screw shouldn¿t loosen or detach and it contributed to incident.In the time when the event occurred the device was being used for patient treatment.When reviewing similar reportable events for the same device, we have been able to find several similar fault descriptions compared to the situation investigated here, in none a serious injury or worse occurred.Despite a relatively large base of installed products, used continuously, there appears to be only a very low ratio of this type of event with a stable baseline occurrence rate.The supplier of the spring arms led several tests on a spring arm performing 20.000 cycles of up and down movement.The test with a loosened screw, with a complete turn back, shows that it¿s the only case where the screw continues to loosen.The customer informed us that the maintenance of these devices was performed by the maintenance staff of the hospital, without providing us the record of this maintenance operation.Therefore, it is unknown if the tightening of the fitting screws has been verified.Moreover, in the case where the tightness of the fitting screws has been checked, we do not know if this verification has been made visually or by using a tool (allen wrench).Therefore, there are 2 possible root causes: ¿ the supplier ondal did not tighten correctly the screw during the manufacturing of the spring arms.¿ the tightening of the screws was not adequately verified during the annual maintenance.To prevent the loosening and the fall of the screw / washer, the technical manuals indicate to check all the fixing screws and to check the hold of the spring arm covers during yearly preventive maintenance.The screws have a long threading, its loosening is visually detectable during cleaning or during yearly preventive maintenance.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• 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: 10422758
• MDR Text Key: 203476670
• Report Number: 9710055-2020-00333
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569202915
• Device Catalogue Number: ARD569202915
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1