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

Model Number LP-20-120

Device Problems Leak/Splash (1354); Dent in Material (2526)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Customer stated "eval".Repair tech stated "unit only with dent in top case - failed coag leakage - adjusted r77.Followed up with repair tech ed mak regarding explanation on "failed coag leaking".Leep precision generator lp-20-120.E-complaint- (b)(4).

Event Description

Customer stated "eval".Repair tech stated "unit only with dent in top case - failed coag leakage - adjusted r77.Followed up with repair tech (b)(4) regarding explanation on "failed coag leaking".1216677-2021-00113 leep precision generator lp-20-120 (b)(4).

Manufacturer Narrative

Investigation x-review dhr x-inspect returned samples.*analysis and findings (b)(4).Distribution history: this complaint unit was manufactured at csi on 2/1/07 under wo #(b)(4) and shipped on (b)(6) 2019.Manufacturing record review: dhrs (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 condition.Product receipt: the complaint unit was returned on repair log 96195.Visual evaluation: visual examination of the complaint unit revealed physical damage.The top of the unit was dented.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Service & repair further evaluated the unit and did note the coag leakage failed.The resulting values was found to be outside parameters but not obvious in function without a proper check by qualified personnel.Root cause: complaint notes a request for an evaluation with no description of a failure.Unit was not found to have a functional defect and the unit arrived with improper packing with a dent noted on the top of the device.The dent is viewed as having occurred during the cusotmer's possession.The available information suggests the unit was impacted and the customer deemed the unit required an evaluation.During the evaluation r77 required an adjustment to have the resulting wattage set within acceptable parameters.However, under default settings in coag, the use of the device would not clearly indicate r77 would require an adjustment.A definitive root cause cannot be determined.*correction and/or corrective action the unit's r77 was adjusted, tested to specifications and returned to the customer.No further corrective action is necessary.*preventative action activity coopersurgical will continue to monitor this complaint condition for 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: 11862360
• MDR Text Key: 262959835
• Report Number: 1216677-2021-00113
• 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
• Remedial Action: Modification/Adjustment
• 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: 05/21/2021
• 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: 04/23/2021
• 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