MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN.; LEEP 1000

Model Number 52969

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

Reference e-complaint: (b)(4)."electricity stops when being used." s&r log # 85743.

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• 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: 6574794
• MDR Text Key: 75606020
• Report Number: 1216677-2017-00032
• 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
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/18/2017

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 Operator: Physician
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2007
• 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