MAUDE Adverse Event Report: COOPERSURGICAL, INC. MARS 1800 LAF

Model Number WM1800

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

Report as per request from fda medwatch program.

Event Description

"removed the motor -burnt my hand." (b)(4).

• Brand Name: MARS 1800 LAF
• Type of Device: MARS 1800 LAF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5922517
• MDR Text Key: 249922437
• Report Number: 1216677-2016-00036
• Device Sequence Number: 1
• Product Code: PUB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WM1800
• Device Catalogue Number: WM1800
• Device Lot Number: 2014-12-03-0348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other