MAUDE Adverse Event Report: MAQUET S.A.S. POWERLED

Model Number PWD700SFK3

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

The customer reported to maquet sas that during position of the lighthead, some metal dust, at the junction between the fork and the spring arm, fell down on to the surgical field.No injuries were reported.(b)(4).

Manufacturer Narrative

A maquet tech evaluated that the cause of the metal dust is related to a lack of grease at the junction between the fork and the spring arm, leading to a grinding during manipulation of the lighthead.Maquet has not been informed of any maintenance being done on this device.In the powerled operating manual, maquet suggests to customers that the light should be removed and lubricated at the sleeve every year by a certified tech.The tech replaced the fork, added grease, and returned the device to service.

• Brand Name: POWERLED
• Manufacturer (Section D): MAQUET S.A.S.; ardon, orleans cedex 2 ; FR
• Manufacturer Contact: marie-francoise cabel ; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 45074 ; FR 45074 ; 37013004
• MDR Report Key: 4574742
• MDR Text Key: 19309381
• Report Number: 9710055-2015-00019
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PWD700SFK3
• Device Catalogue Number: 568411010C
• Other Device ID Number: 568370931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1