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

Model Number LP-20-120

Device Problem Sparking (2595)

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

Event Date 06/18/2019

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.Reference: (b)(4).

Event Description

Customer stated "sparking." reference repair order (b)(4).

Event Description

Customer stated "sparking" reference repair order # (b)(4).Ref - (b)(4).

Manufacturer Narrative

Reference : e-complaint-(b)(4).Investigation x-review dhr x-inspect returned samples.Analysis and findings distribution history: this complaint unit was manufactured at csi on 12/16/15 under wo #'s (b)(4) and shipped on 12/17/15.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 attached 2-year complaint history showed one similar reported complaint condition.The complaint was not confirmed.Product receipt: the complaint unit was returned on a repair.However, based on log 92217, this unit was at csi on 6/18/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Service & repair did not confirm the complaint unit.This unit's main board was noted to have no zener diode and updated regardless of being non-rohs.A recall (1216677-05-24-2019-002-r) has been issued for foot pedal activation failures primarily detected on rohs boards.A review of the occurrence pinpointed the update to rohs resulted in instances of foot pedal failures and addressed by the recall and capa 725.This unit was not on complaint for this failure.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 the unit was updated with the zener diode, tested to specifications 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? no.*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: 8951312
• MDR Text Key: 156450072
• Report Number: 1216677-2019-00245
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• 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: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other