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

Model Number LP-20-120

Device Problems Failure to Cut (2587); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Report submitted by csi service & repair trumbull.End-user - (b)(6) md, stated- we set up the leep machine as we always have done and had the patient's grounding pad placed correctly.When i started the leep procedure, the machine stopped cutting a few seconds activation with the pedal.I started to remove the anterior cervical tissue and was about half way through the specimen when the machine stopped cutting.It continued to make a sound like it was active but was not working.Additionally, the display kept resetting itself and we had to re-configure it about 15 times during the procedure.The cessation of cutting function seemed to correspond to the display resetting itself and suggests a problem internal to the computerized workings of the device.Also, the cessation of cutting function seemed to happen faster and faster as we continued to proceed with the procedure, in other words, the device cut for shorter and shorter intervals of time the longer we tried to reset it and use it.We confirmed that the grounding pad was well attached and all the devices were firmly plugged in.Leep precision intg sys lp-10-120 e-complaint (b)(4).

Manufacturer Narrative

11/16/2021: follow up report for part number amendment previously reported as lp-10-120 amended to lp-20-120.Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Report submitted by csi service & repair trumbull: end-user: (b)(6), stated: we set up the leep machine as we always have done and had the patient's grounding pad placed correctly.When i started the leep procedure, the machine stopped cutting a few seconds activation with the pedal.I started to remove the anterior cervical tissue and was about half way through the specimen when the machine stopped cutting.It continued to make a sound like it was active but was not working.Additionally, the display kept resetting itself and we had to re-configure it about 15 times during the procedure.The cessation of cutting function seemed to correspond to the display resetting itself and suggests a problem internal to the computerized workings of the device.Also, the cessation of cutting function seemed to happen faster and faster as we continued to proceed with the procedure, in other words, the device cut for shorter and shorter intervals of time the longer we tried to reset it and use it.We confirmed that the grounding pad was well attached and all the devices were firmly plugged in.1216677-2021-00159.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 03/12/2019 under wo #(b)(4) and shipped on 5/14/2019.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 repair log (b)(4).Visual evaluation: visual examination of the complaint unit revealed physical damage (a dent) to the top chassis.Functional evaluation: complaint unit was functionally evaluated and appeared to function properly.However, upon testing the unit was noted to require an adjustment on r77 to within specification.This to prevent coag leakage.The unit did not exhibit cut failures before or after the adjustment.Root cause : no definitive root cause for this issue could be reliably determined at this time.The problem description suggests an interruption in power supply to the generator.Two potential reasons may be the unit was not have been plugged into a dedicated wall outlet or the generator was not fully seated into the cart.Neither can be confirmed with the available information.Correction and/or corrective action: the unit was adjusted and tested to specifications.Upon completion the unit was returned to the customer.No further corrective action is necessary.Preventative action activity : (b)(6) will continue to monitor this complaint condition for trends.

Event Description

Report submitted by (b)(6).End-user - (b)(6) md, stated- we set up the leep machine as we always have done and had the patient's grounding pad placed correctly.When i started the leep procedure, the machine stopped cutting a few seconds activation with the pedal.I started to remove the anterior cervical tissue and was about half way through the specimen when the machine stopped cutting.It continued to make a sound like it was active but was not working.Additionally, the display kept resetting itself and we had to re-configure it about 15 times during the procedure.The cessation of cutting function seemed to correspond to the display resetting itself and suggests a problem internal to the computerized workings of the device.Also, the cessation of cutting function seemed to happen faster and faster as we continued to proceed with the procedure, in other words, the device cut for shorter and shorter intervals of time the longer we tried to reset it and use it.We confirmed that the grounding pad was well attached and all the devices were firmly plugged in.1216677-2021-00159, (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 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: 12327775
• MDR Text Key: 268325626
• Report Number: 1216677-2021-00159
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• 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,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 07/28/2021
• 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