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

Model Number 52969

Device Problem Output Problem (3005)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Ref. #: (b)(4). Report as per request from fda medwatch program. This is to bring to your attention that we are in receipt of several supplement reports submitted by cooper surgical, inc. , please be informed that there is no record of initial report submissions in emdr system. It appears that follow-up #1 could be actual initial report, but may have been erroneously submitted as follow-up in error. Kindly verify the supplement reports listed below, and resubmit follow-up #1 report as initial report electronically through esg web trader by checking only "initial" box, and advise when complete.

Event Description

Review of service and repair log #: 84194. Follow up questionnaire: "intermittent failure to cauterize. " reference complaint: (b)(4).

• 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: 6307153
• MDR Text Key: 222025270
• Report Number: 1216677-2016-00090
• 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 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: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 52969
• Device Catalogue Number: 52969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/07/2017 Patient Sequence Number: 1