MAUDE Adverse Event Report: COOPERSURGICAL INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problem No Display/Image (1183)

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

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Investigation underway.

Event Description

Intermittent foot pedal function (suspect panel socket or main pcb).Display went blank during use.Handpiece activation does function.No patient injury reported on (b)(6) 2016.(b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint will be returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Follow up (b)(6) 2016, investigation: initiated manufacturer's investigation, no sample returned.X- review dhr.X- inspect returned samples.Inspect stock product.Analysis and findings: a review of the 2 years complaint history reveals similar issue.A review of the dhr reveals no anomalies.The complaint unit, leep precision intg.Sys., p/n-lp-10-120 and serial#(b)(4), was received with intermittent coag output; the foot pedal and hand piece activation both fail.Repair tech had confirmed that pc board was bad inside.The complaint was confirmed after evaluation.The unit was built in august of 2016 and it was 100% inspected prior to release.The replacement unit was sent back to the customer (replacement order#(b)(4)).After pcb replacement the complaint unit was restocked as demo.There is no definitive root cause available for this complaint condition.The potential root cause could be related to bad components.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Correction and/or corrective action": the complaint unit was returned back to stock as demo.The customer had received a replacement unit.This complaint will be entered into the cooper surgical continuous improvement plan (cip).

Event Description

Intermittent foot pedal function ( suspect panel socket or main pcb).Display went blank during use.Handpiece activation does function.No patient injury reported on (b)(6) 2016.Reference (b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP PRECISION INTG. SYS.
• Manufacturer (Section D): COOPERSURGICAL INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6169464
• MDR Text Key: 62676042
• Report Number: 1216677-2016-00087
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other