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

Catalog Number 567702904

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by manufacturing site.

Event Description

On 29th october, 2017 maquet sas became aware of an incident with one of surgical lights- power led.As it was stated, camera detached from light head during surgery and hang on wiring.There was no patient involved however we decided to report it in abundance of caution.(b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light powerled device.It was stated that the camera detached from the light head during surgery and hang on wiring.There was no patient involved however it was decided to report the event in abundance of caution.It was established that when the event occurred, the light-head did not meet its specification and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that there is no apparent increase in trend with the issue at hand and that the reported scenario has never lead, to date, to serious injury or worse.This failure occurs due to tearing of the housing located on 6 screws.The contributing factors can be excessive or repetitive stresses during the manipulation of the camera.It appears the issue is only likely to concern devices of this model that are 7 years or older.

Event Description

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): FREDERIC LELEU - 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: 6983680
• MDR Text Key: 91255968
• Report Number: 9710055-2017-00068
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 567702904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1