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

Model Number LP-20-120

Device Problems No Display/Image (1183); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Will not power up correctly to operate.Display fades out does not operate.Order: 94559 from account after follow up: when turning on the unit the led was very dim and in a few seconds the led display would be completely off.I would cycle the power and there would be no display visible.After the unit was power off for about 5 minutes and power cycled back on the same thing would happen again with the led being dim and quickly fading out.I did not witness or hear of an issue with the foot pedal.This was noticed before a procedure.Ref : e-complaint-(b)(4).Leep precision generator lp-20-120 e-complaint-(b)(4).

Event Description

Will not power up correctly to operate.Display fades out does not operate.Order: (b)(4).From account after follow up: when turning on the unit the led was very dim and in a few seconds the led display would be completely off.I would cycle the power and there would be no display visible.After the unit was power off for about 5 minutes and power cycled back on the same thing would happen again with the led being dim and quickly fading out.I did not witness or hear of an issue with the foot pedal.This was noticed before a procedure.Ref : (b)(4).1216677-2020-00169 leep precision generator lp-20-120 (b)(4).

Manufacturer Narrative

Investigation: x-review dhr.X-inspect returned samples.Analysis and findings: complaint #2020-07-0000211.Distribution history: this complaint unit was manufactured at csi on 6/9/2017 under wo #(b)(4) and shipped on 7/12/2017.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 no similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair.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 : the zener diode z1 protects z2 and functioned as designed.A check on the regulator providing the 5 volts (dc) to the display board was operating as expected and at 0.2amps.Once the z1 diode was removed, the board was powered up due to being in parallel with z2.The diode is activated at 5.3 to 5.8 volts and is not operating until it sees a voltage in this range.Once exposed to a voltage in this range it is operational.As the regulator has a steady output of 5 volts, this component is primarily not in use/activated.To burn out as it did, it would have to have been activated and would see at a minimum of 1 watt which is twice its rating.Alternatively, if damaged it may have been compromised to lend itself to be prematurely prone to burning out.No definitive root cause for this issue could not be reliably determined at this time.It is likely the diode was damaged or defective and the failure of z1 is considered confined to this component.Was the complaint confirmed? yes.Correction and/or corrective action: none.Reason: no further training required at this time.The unit was fitted with a new board, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10395820
• MDR Text Key: 209163968
• Report Number: 1216677-2020-00169
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other