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

Model Number LP-10-120

Device Problems Device Stops Intermittently (1599); Failure to Cut (2587)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has been returned by the customer and is being evaluated.Once the investigation is completed, a follow-up report will be filed.(b)(4).

Event Description

Per repair authorization form: "cuts intermittently, inconsistent seems to be loosing contact.Having to make cuts multiple times." (b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has been returned by the customer and is being evaluated.Once the investigation is completed a follow-up report will be filed.(b)(4).Follow up: 07/22/2016.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 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.The unit was evaluated by service and repair.The complaint was confirmed to have an output failure where the unit had intermittent function in coag.This unit was manufactured january 2015.Units must pass in-process inspections before they are shipped out from stock.A root cause for this complaint condition is not readily available but may be due to a faulty component that gave out over the year.Correction and/or corrective action: the customer received a new unit.As there is no process in place to determine if a particular component is failing or the personnel to do so this unit was scrapped out, trans # (b)(4).This complaint will be entered into the coopersurgical continuous improvement plan (cip).Corrective action level: 4.Train personnel.X-none.Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.

Event Description

Per repair authorization form: "cuts intermittently, inconsistent seems to be loosing contact.Having to make cuts multiple times." (b)(4).

• Brand Name: LEEP PRECISION GENERATOR
• Type of Device: LEEP PRECISION GENERATOR
• 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 cprporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614230
• MDR Text Key: 44724669
• Report Number: 1216677-2016-00008
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• 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
• Device Lot Number: N/.A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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