MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000-110V; LEEP 1000

Model Number L1000

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

Report as per request from fda medwatch program.

Event Description

Review of service and repair logs (b)(4).Per repair authorization form "foot pedal stops working during case" "disconnecting and reconnecting foot pedal causes cautery to start working again" ref : (b)(4).

• Brand Name: LEEP SYSTEM 1000-110V
• Type of Device: LEEP 1000
• 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: 6392885
• MDR Text Key: 240015794
• Report Number: 1216677-2016-00077
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2005
• 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