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

Model Number LP-20-120

Device Problems Smoking (1585); Failure to Cut (2587)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Will not cut, started smoking.Complaint verified.Replaced pcb.Order: (b)(6).Ref : (b)(4).Leep precision generator lp-20-120 (b)(4).

Event Description

Will not cut, started smoking.Complaint verified.Replaced pcb.Order: (b)(4).Ref : (b)(4).1216677-2020-00185 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 10/28/2019 under wo #269845 & 269835 and shipped on (b)(6) 2019.Manufacturing record review: dhr's 269845 & 269835 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 94712.Visual evaluation: visual examination of the complaint unit revealed no physical damage.However, once opened, there was internal damage to the display board components, r9 & r14.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause : an initial investigation by (b)(6) (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 / *preventative action activity the customer was provided with a new generator.The complaint unit was evaluated by technical operations.As a result, the resistors are to be upgraded to a higher rating.Reference (b)(4), (b)(4), (b)(4), and (b)(4) and capa (b)(4).No further training required at this time.

• 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: 10440586
• MDR Text Key: 205096038
• Report Number: 1216677-2020-00185
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2020
• 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: 08/12/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other