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

Model Number PWD700SFHDK3

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

Feb.02, 2016 02:39 pm (gmt-5:00) added by (b)(6): maquet service examined the device and found that the screws that fix the camera to the light head had pulled through the plastic mount plate.The camera was held back by its cables.The problem was caused by an excessive mechanical stress during manipulation of the camera.Pending repair of the camera, the surgical light was returned to service by replacing the broken camera with a sterilized handle.(b)(4).

Event Description

The customer informed maquet service that the video camera of a surgical light detached and was hanging by its wires.The incident occurred during a procedure,when the o.R.Staff repositioned the light.No patient injury was reported.(b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MAQUET SAS; orléans cedex 2 ; FR

orléans cedex 2 

• MDR Report Key: 5405507
• MDR Text Key: 37722331
• Report Number: 9710055-2016-00007
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD700SFHDK3
• Device Catalogue Number: 568320905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1