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).

Manufacturer Narrative

Investigation no sample returned review dhr analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 5/18/2021 under wo # (b)(4) and shipped on 6/4/2021.Manufacturing record review: dhr's 297985 & 304222 were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint unit was not possible as the unit was not returned.Functional evaluation: a functional evaluation was not possible as the unit was not returned.Service & repair provided input pointing out the generator's position is required to be fully in place to the back of the opening to make proper contact with the power receptacle.Root cause: the root cause for this complaint condition is not definitively determined.However, based on the information on this complaint, handling is considered a contributing factor.Pulling a connection off the front panel without securing the generator's position can cause the generator to move forward.This can produce a loose connection in the back where the unit connects to the integration unit.Was the complaint confirmed? no correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

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.1216677-2021-00265 leep precision int sys lp-10-120 e-complaint-(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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other