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

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an issue with one of surgical lights- powerled.As it was stated by the customer, the interface ring for the handle is broken.There was no injury reported however we decided to report the issue in abundance of caution.(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

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.A follow-up medwatch will be submitted when additional information becomes available.

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

The issue is still being investigated by manufacturing site.(b)(4).The issue is still being investigated by manufacturing site.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Manufacturer reference number (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.(b)(4).Maquet sas became aware of an issue with surgical light powerled device.As it was stated by the customer, the interface ring for the handle broke off.Fortunately, there was no adverse outcome reported however, we decided to report the issue based on the potential for contamination if the situation was to reoccur, as any object falling into the sterile field might be the source of cross contamination.It was established that when the event occurred, the surgical light did not meet its specification 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.There is no trend observed for this failure mode.The most probable root cause is a radial force applied on the handle.Although a handle is centered into the cupola, an excessive radial force ¿for example a collision with another heavy object or device - could have weakened and damaged the interface handle at this location.What is more, every user need to check the sterilizable handle daily with regards to its proper functioning.If any anomalies is found , the handle shall be replaced (according the powerled user manual 01581en ed.06 page 38).Maquet sas decided to start a modification process to enhance the part.Similar material, already used on a different part, is to be tested.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• MDR Report Key: 7609339
• MDR Text Key: 111880079
• Report Number: 9710055-2018-00045
• 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
• Remedial Action: Replace
• 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: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1