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

Model Number ARD568350933

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The issue isbeing investigated by manufacturing site.(b)(4).

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.As it was stated, the circlip was defective.There is no injury reported however we decided to report the issue in abundance of caution as any part falling might be a source of contamination.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number: (b)(6).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074; exemption # e2018005.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Maquet sas became aware of an incident with surgical light powerled 500 device.As it was stated by the customer, the circlip broke on the handle.There was no injury reported however we decided to report the issue based on the potential related to falling parts being potential source of contamination.During the investigation it was found that we have received similar complaints in the past, however none of them have led to serious injury or worse.The involved handle is used to maneuver the surgical light to correctly set the light¿s illumination over the surgical area.It was established that when the issue occurred, the device did not meet its specification and it contributed to the complaint.It was not established that at the time when the issue was noticed the device was or was not being used for patient treatment.The fixation handle is a part that is easily removable and must be sterilized in a sterilizer after each surgical procedure.The locking mechanism is composed by a steel axis, a spring and a circlip.It was reported that a part of the locking mechanism on the handle (circlip) was broken.It was confirmed by tests results that the most likely root cause of the breakage of circlips is corrosion of a2 steel.Therefore, it was decided to change the material to a4 stainless steel.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7960892
• MDR Text Key: 123821391
• Report Number: 9710055-2018-00099
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1