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

Model Number LP-20-120

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 05/31/2019

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 "electrical issue" reference repair order # (b)(4).(b)(4).

Event Description

Customer stated "electrical issue".Reference repair order #(b)(4).Ref: (b)(4).

Manufacturer Narrative

Reference : (b)(4).Investigation: x-review dhr, x-inspect returned samples.Analysis and findings : distribution history: this complaint unit was manufactured at csi on 02/12/16 under wo #182217 & 177437 and shipped on 3/8/16.Manufacturing record review: dhrs 182217 & 177437 were reviewed and no non-conformities were noted.Incoming inspection review: not applicable.Service history record: one additional service history record was found for this unit in april of 2019.The complaint note was for a leakage error that was not confirmed on log 91884.A new board was installed.Historical complaint review: a review of the attached 2-year complaint history does not have a similar "electrical" complaint condition reported.Product receipt: the complaint unit was returned on a repair.However, based on log 92241, this unit was at csi on 6/20/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action service & repair replaced the board as a precautionary measure.The unit was tested to specification and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? yes.Preventative action activity coopersurgical will continue to monitor this complaint condition for any 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: 8961659
• MDR Text Key: 156715813
• Report Number: 1216677-2019-00248
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• 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: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other