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

Model Number PWD500SFVIDEOHDL

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician (fst) evaluated the device and found that the camera mounting screws had pulled out of the mounting plate.Maquet determined that the failure was caused by an excessive mechanical stress during manipulation of the camera.The powerled operating manual includes a pre-use verification that the camera is properly held in place.Additionally the device was directly involved with the reported incident and was being used for treatment for diagnosis of the patient when the event occurred.The fst repaired the device and returned it to service.

Event Description

The customer reported that, during a surgery, the handle broke while the surgeon was trying to move it and the camera was hanging by the wires.There were no injuries 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): 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: 6221730
• MDR Text Key: 64184247
• Report Number: 9710055-2017-00004
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD500SFVIDEOHDL
• Device Catalogue Number: 568320904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Date Device Manufactured: 01/31/2011
• 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