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

Model Number ARD567913905

Device Problem Sharp Edges (4013)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with powerled ii surgical light.As it was stated, the devon handle used with surgical light has sharp edges.There was no injury reported, however, we decided to report the issue based on the potential as sharp edges on accessible part of the device are creating risk of injury for operator of the device.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of h4 device manufacture date deems required.This is based on internal evaluation of available data.H4 device manufacture date: previous: 2019-06-25.Corrected: 2019-06-26.

Event Description

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

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with powerled ii surgical light.As it was stated, the devon handle -a non-getinge part-used with surgical light has sharp edges.There was no injury reported, however, we decided to report the issue based on the potential as sharp edges on accessible part of the device are creating risk of injury for operator of the device.During investigation, it was found that the powerled ii device was according to the manufacturer¿s specification, and the part on which the malfunction occurred was not sold by getinge.There is no information if in the time when the event occurred, the device was or was not being used for patient treatment and it contributed to the event.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the manufacturer information, the product affected was not a getinge product even although it was used on a powerled ii arm.Therefore, the most likely root cause of the allegation in this complaint cannot be established.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• 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: 11520256
• MDR Text Key: 241419686
• Report Number: 9710055-2021-00103
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD567913905
• Device Catalogue Number: ARD567913905
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2021
• Patient Sequence Number: 1