MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR; LEEP,

Model Number LP-20-120

Device Problem Output Problem (3005)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Ref e-complaint (b)(4).Report as per request from fda medwatch program.

Event Description

Reference e-complaint- (b)(4)."the leep would not coagulate after cutting.The tone during coag faded out as the power to the electrode also did.They had to use other means to stop the bleeding.Patient is ok." s&r log # (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP,
• 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: 6722136
• MDR Text Key: 238842945
• Report Number: 1216677-2017-00043
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention