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

Model Number LP-20-120

Device Problem Failure to Cut (2587)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

Customer stated "does not cut - when performing a leep procedure machine would not cut.Has been cleared by clinical engineering thru this facility." repair tech stated "complaint verified.Replaced pcb" reference repair order # (b)(4).Ref : e-complaint- (b)(4).Leep precision generator lp-20-120 e-complaint- (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 9/23/2019 under wo #'s (b)(4) and shipped on 11/1/2019.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 a repair.However, based on log 95029, this unit was at csi on 10/6/2020.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 : initially, a loose component (coil on t5) was found in contact with mod1 and repaired which appeared to have corrected the rf failure in cut mode.However, upon functional testing rf leakage was present in the blend mode.No definitive root cause for this issue could be reliably determined at this time.The loose component is viewed to have been jarred loose due to insufficient epoxy.Correction and/or corrective action : the unit was fitted with a new board, tested to specifications and returned to the customer.The failed board was set aside for additional evaluation by csi ee's.No further corrective action is necessary at this time.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Customer stated "does not cut - when performing a leep procedure machine would not cut.Has been cleared by clinical engineering thru this facility." repair tech stated "complaint verified.Replaced pcb" reference repair order #(b)(4).Ref : (b)(4).1216677-2020-00239 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: 10704968
• MDR Text Key: 242232973
• Report Number: 1216677-2020-00239
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/29/2022
• 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