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

Model Number LP-20-120

Device Problems Failure to Cut (2587); Output Problem (3005)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Customer stated-outputs fractional of set value.Complaint not verified-no trouble found, updated r8 & c14 (b)(4).No harm to either, because unit had little to no output for users, so unit was unable to cut tissue for them.Leep precision generator lp-20-120.E-complaint (b)(6).

Event Description

Customer stated-outputs fractional of set value complaint not verified-no trouble found, updated r8 & c14 ro 96778 no harm to either, because unit had little to no output for users, so unit was unable to cut tissue for them.1216677-2021-00227 leep precision generator lp-20-120 e-complaint(b)(4).

Manufacturer Narrative

Investigation x-review dhr x-inspect returned samples *analysis and findings complaint #2021-09-0000239 distribution history: this complaint unit was manufactured at csi on 02/05/2016 under wo #182217 & 177437 and shipped on (b)(6) 2016.Manufacturing record review: dhr's 182217 & 177437 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 conditions.Product receipt: the complaint unit was returned on repair log 96778.Visual evaluation: visual examination of the complaint unit revealed no outer physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause : the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action the units' board was updated to the latest revision, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 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: 12615865
• MDR Text Key: 278167149
• Report Number: 1216677-2021-00227
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other