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

Model Number LP-20-120

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.

Event Description

Does not provide power to pen.(b)(4).Leep precision generator lp-20-120.

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 1/29/2015 under wo #(b)(4) and shipped on 4/13/2015.Manufacturing record review: dhr's 174927 & 174956 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 (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause : a loose nut on bj3 interrupted power to cut mode.The pen connects to bj1 thru bj3 where power is supplied through bj1 and bj2 is for coag.Any one of the nuts being loose will interrupt proper flow of power.As this unit was not previously sent in for servicing, the loose nut on bj3 is suspected to have worked its way loose over the past 5 years where the other nuts have not.Although there is a heavy duty lock washer in place slight differences in the force used is likely to have contributed to this loose nut.*correction and/or corrective action: service & repair re-tightened the nut on bj3.The unit was re-tuned, tested to specifications, and returned to the customer.A torque value was assigned when securing the nuts on bj1 thru bj3 to harmonize the force used to secure the nut in place.Technical operations to process this update on the print ((b)(4)) when addressing an un-related issue captured on capa 731.No further training required at this time.*preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Does not provide power to pen.Order: (b)(4) ref: (b)(4).Leep precision generator lp-20-120 (b)(4).

• 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: 10169699
• MDR Text Key: 199683447
• Report Number: 1216677-2020-00133
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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