MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG.

Model Number 909075

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2016

Event Type  malfunction  

Event Description

Review of repair order log 82001.Per repair authorization form power cut to pencil in cut blend and coag during leep procedure.Reference (b)(4).

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• 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 coporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6392558
• MDR Text Key: 245491885
• Report Number: 1216677-2016-00040
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 909075
• Device Catalogue Number: 909075
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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