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

Model Number LP-20-120

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

Customer stated-the loop does not heat enough to burn/cut.Customer verified-r9 and r14 burnt, r8 and c14 update done, ac cord not grounded ro 96832 1216677-2021-00209 leep precision generator lp-20-120 e-(b)(4).

Manufacturer Narrative

Investigation x-review dhr x-inspect returned samples.*analysis and findings complaint #(b)(4).Distribution history: this complaint unit was manufactured at csi on 01/13/2020 under wo #'s (b)(4) and shipped on 02/27/2020.Manufacturing record review: dhr's (b)(4) 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 similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 96832.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once opened, the internal damage to the display board components, r9 & r14 was noted.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause : an initial investigation by technical operations (csi's engineering dept.) has indicated resistors r9 and r14 were burnt out due to being exposed to current outside their rating.The root cause of this issue has been attributed to under rated resistors.*correction and/or corrective action the units' board was updated to the latest revision, tested to specifications and returned to the customer.The resisters were updated to a higher rating on the boards via (b)(4).A redline was provided to the board vendor to produce boards in their wip to include the new resistors and csi inventory was re-worked (wo #(b)(4)) to have the resistors replaced.Ref capa 731.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Customer stated-the loop does not heat enough to burn/cut.Customer verified-r9 and r14 burnt, r8 and c14 update done, ac cord not grounded ro (b)(4).1216677-2021-00209 leep precision generator lp-20-120 e-complaint-(b)(4).

• 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: 12562471
• MDR Text Key: 276906853
• Report Number: 1216677-2021-00209
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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