MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION

Model Number LP-10-120

Device Problems Disconnection (1171); Compatibility Problem (2960); Unintended Movement (3026)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc. Is investigating the reported conditon.

Event Description

Per csi service & repair trumbull. Customer states the leep unit disconnects from the power socket in the cart when they pull out the return pad (grounding) cable. This in turn loses power with the unit. Customer states this has not occurred with previous generations of the device. Based on the information reported to csi service and repair; there is no report that the device while fully connected did not perform as intended , there was no report of intermittent power during use , additionally there was no report of the device ceasing to function on its own during use while connected to the power supply source. There was no report of adverse event, injury, or medical intervention with regards to patient care. Leep precision int sys (b)(4).

Manufacturer Narrative

Coopersurgical, inc. Is investigating the reported conditon.

Event Description

Per csi service & repair trumbull. Customer states the leep unit disconnects from the power socket in the cart when they pull out the return pad (grounding) cable. This in turn loses power with the unit. Customer states this has not occurred with previous generations of the device. Based on the information reported to csi service and repair; there is no report that the device while fully connected did not perform as intended , there was no report of intermittent power during use , additionally there was no report of the device ceasing to function on its own during use while connected to the power supply source. There was no report of adverse event, injury, or medical intervention with regards to patient care. Leep precision int sys (b)(4).

• Brand Name: LEEP PRECISION
• Type of Device: LEEP PRECISION
• 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: 12824992
• MDR Text Key: 285339264
• Report Number: 1216677-2021-00265
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 11/16/2021 Patient Sequence Number: 1