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

Model Number LP-20-120

Device Problems Failure to Cut (2587); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc. Is currently investigating the reported condition.

Event Description

Report submitted by csi service & repair trumbull. End-user - (b)(6) md, stated- we set up the leep machine as we always have done and had the patient's grounding pad placed correctly. When i started the leep procedure, the machine stopped cutting a few seconds activation with the pedal. I started to remove the anterior cervical tissue and was about half way through the specimen when the machine stopped cutting. It continued to make a sound like it was active but was not working. Additionally, the display kept resetting itself and we had to re-configure it about 15 times during the procedure. The cessation of cutting function seemed to correspond to the display resetting itself and suggests a problem internal to the computerized workings of the device. Also, the cessation of cutting function seemed to happen faster and faster as we continued to proceed with the procedure, in other words, the device cut for shorter and shorter intervals of time the longer we tried to reset it and use it. We confirmed that the grounding pad was well attached and all the devices were firmly plugged in. Leep precision intg sys lp-10-120 e-complaint (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12327775
• MDR Text Key: 268325626
• Report Number: 1216677-2021-00159
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/16/2021 Patient Sequence Number: 1