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

Model Number LP-20-120

Device Problem Failure to Power Up (1476)

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

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint condition reported is currently being investigated by coopersurgical, inc.Reference: (b)(4).

Event Description

Customer stated "unit will not power handpiece".Reference repair order #: (b)(4).Ref: (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 11/25/14 under wo #(b)(4) & (b)(4) and shipped on 12/17/14.Manufacturing record review: dhr's (b)(4) & (b)(4) were reviewed and non-conformities, unrelated 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 a repair.However, based on log 93492 this unit was at csi on 12/12/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found the coag mode was not functioning properly.Upon inspection of the device internally, a loose bj2 was noted.This is one of 3 connectors for the hand piece/pencil and correlates to the complaint description concerning no hand piece operation.The bj3 is for the cut mode and also noted to be slightly loose as was bj1, the power supply.Root cause : a definitive root cause for this issue could not be reliably determined at this time.All units are put through in-process testing including checks on output for all modes.Coopersurgical will continue to monitor this complaint condition for trends.*correction and/or corrective action service & repair re-tightened the nut on bj2.The unit was tested to specifications, and returned to the customer.A torque value was assigned when securing the nuts on bj1 thru bj3.Technical operations to process this update on the print when addressing an un-related issued captured on capa 731.

Event Description

Customer stated "unit will not power handpiece" reference repair order #(b)(4).Ref: (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9672946
• MDR Text Key: 191402888
• Report Number: 1216677-2020-00028
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other