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

Model Number LP-20-120

Device Problem Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported conditon.

Event Description

Coag interm.Doesn't give adequate energy with foot p.And p.Cord.Order: (b)(4).From follow: i just asked dr.(b)(6) and she said there was excessive bleeding and she thinks it lasted between 20-30 minutes.There were 2 patients that day that had a leep and the same thing happened to both.Complaint not verified.1216677-2021-00109 leep precision generator lp-20-120 (b)(4).

Event Description

Coag interm.Doesn't give adequate energy with foot p.And p.Cord.Order: (b)(4) from follow: i just asked dr.Chuu and she said there was excessive bleeding and she thinks it lasted between 20-30 minutes.There were 2 patients that day that had a leep and the same thing happened to both complaint not verified.1216677-2021-00109.Leep precision generator lp-20-120 (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 09/09/2020 under wo #'s 280419 & 280397 and shipped on 10/06/2020.Manufacturing record review: dhr's 280419 & 280397 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 reveal similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log (b)(4).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 complaint condition was not duplicated therefore not confirmed.The unit is no longer available for further evaluation.However, based on the complaint description this complaint may be related to coag failures confirmed on a previous unit resulting in capa 744.The investigation on the previous unit had found the component on u8, of the display board, had insufficient isolation and susceptible to interference that can produce improper coag function.Observation: upon evaluation the bj2 nut was noted to be slightly loose.Although, the device was not found to be defective with the connector loose, the nut happens to be associated with coag function.*correction and/or corrective action the unit was evaluated, tested to specification and returned to the customer under warranty.The issue was re-evaluated for containment and has resulted on a hold on all leep precisions in stock and in wip until corrective actions can be put in place.To address units in the field for this issue a review of an hhe will precede a decision on a recall.Note: the specification used in the assembly of the main board (300788-r) had been updated to include a called out torque force on bj1, bj2, & bj3.This was a recent update to the print in response to older complaints noted to have similar findings where the nut was loose but not definitively determined to be a direct root cause.*preventative action activity coopersurgical will continue to monitor this complaint condition for any 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: 11850257
• MDR Text Key: 262444991
• Report Number: 1216677-2021-00109
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 04/28/2021
• 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