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

Model Number ARD568330933

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.The screw and nut came off of the handle.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).

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 issue with surgical light powerled 300 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.In the last 5 years, all complaints received on that failure were originated from germany.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 if the device was or was not being used for patient treatment at the time of issue occurrence.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.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

This #1 follow-up report is being sent as the initial submission contained an incorrect date aware date reference in section b and g.The aware date in section b was noted as (b)(6)2018 instead of (b)(6) 2018.Section g -date received by manufacturer was also incorrectly noted as (b)(6) 2018 instead of (b)(6)2018.This follow-up report serves to correct both errors.The issue is still being investigated by manufacturing site.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.

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights- powerled.The screw and nut came off of the handle.We decided to report the issue in abundance of caution as any part falling might be a source of contamination.Manufacturer reference number (b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): PASCAL JAY - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 7938589
• MDR Text Key: 123209633
• Report Number: 9710055-2018-00093
• Device Sequence Number: 0
• Product Code: FSY
• Reporter Country Code: GM
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2019
• 2 Devices were Involved in the Event: 1 2

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: ARD568330933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 09/05/2018; 10/08/2018; 10/08/2018; 10/08/2018; 10/08/2018; 10/08/2018
• Supplement Dates FDA Received: 10/08/2018; 10/29/2018; 12/18/2018; 01/09/2019; 01/31/2019; 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1