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

Model Number POWERLED700SFHDRK3

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Maquet was not able to evaluate the device.The investigation is on-going and the result will be included in a follow-up report.(b)(4).

Event Description

The customer reported that, during an operation, the rubber socket cover fell onto the open surgical site, on the patient.Irrigation was used on the open surgical site, and additional antibiotics were given to the patient.No injuries were 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: 5748344
• MDR Text Key: 48130513
• Report Number: 9710055-2016-00046
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2016,05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: POWERLED700SFHDRK3
• Device Catalogue Number: ARDP.WD229013.C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2016
• Distributor Facility Aware Date: 05/31/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2016
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2013
• 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
• Patient Outcome(s): Other