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

Model Number LP-20-120

Device Problem Loss of Power (1475)

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

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.Once the investigation has been completed a follow up report will be filed.(b)(4).

Event Description

Customer stated "foot pedal w/leep machine stopped working".(b)(4).

Event Description

Customer stated "foot pedal w/leep machine stopped working".Reference repair order: 91863.Ref: (b)(4).

Manufacturer Narrative

Reference: (b)(4).*investigation: x-review dhr.X-inspect returned samples.Analysis and findings : a review of the 2 yr complaint history reveals similar issues.A review of the dhr reveals several boards were replaced due to board failures.Ref ncmr 10966.Service & repair confirmed the complaint condition.Sustaining engineering had identified one issue with a capacitor that had the potential to be overloaded due to excessive current above the capacitors' rating.The part of the circuit that had been found to have an issue on complaint and in production was c21 located on the display board.It's failure affected the foot pedal function due to being shorted.The root cause for this complaint condition is being attributed to a board update from non-rohs to rohs boards.The change had made the c21 capacitor prone to excessive current.The board used in this assembly is prior to the board being updated to include a diode on c21.The diode prevents excessive current from shorting out the component.Correction and/or corrective action: the unit was updated with a zener diode which was put in place to mitigate the c21 component from being overloaded with current.Ecn-21881 was executed to update the print referencing supporting eng-test10487 & eng-test-10504.Remaining boards in stock were updated to include the diode under wo #255846.Capa 725 was issued and a recall (1216677-05-24-2019-002-r) will address the remaining units from the implementation of the rohs board into production up to the addition of the zener diode.Was the complaint confirmed? yes.

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• MDR Report Key: 8659256
• MDR Text Key: 150997291
• Report Number: 1216677-2019-00098
• 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: 12/15/2019

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 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
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 12/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other