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

Model Number LP-20-120

Device Problem Arcing (2583)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

(b)(4).Unit is popping and arcking when in coag.Mode unit was set to 50 on coag & arcking when used.Order: (b)(4).Complaint not verified.Leep precision generator lp-20-120 (b)(4).

Event Description

(b)(4).Unit is popping and arcking when in coag.Mode unit was set to 50 on coag & arcking when used.Order: 95427.Complaint not verified.1216677-2021-00025 leep precision generator lp-20-120 (b)(4).

Manufacturer Narrative

Investigation: x-inspect returned samples: analysis and findings: complaint #(b)(4).Distribution history: this complaint unit was manufactured at csi on 2/09/2016 under wo #182217 & 177437 and shipped on 3/21/2016.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: this unit was returned for an un-confirmed intermittent complaint september 2017 and in february 2017 for a damaged cord.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair log 95427.Visual evaluation: visual examination of the complaint unit revealed no 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.Zener diode updated: this was done to prevent foot pedal failures captured on capa 725 and recall 1216677-05-24-2019-002-r.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• 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: 11358782
• MDR Text Key: 234427881
• Report Number: 1216677-2021-00025
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other