MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 - 110V

Model Number L1000

Device Problems Energy Output Problem (1431); Failure to Cut (2587)

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

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

On 50 watt of blend, the loops especially the wider ones are dragging so much through the tissue, that it is not cutting or cauterizing.(b)(4).

Event Description

On 50 watt of blend, the loops especially the wider ones are dragging so much through the tissue, that it is not cutting or cauterizing.Order: (b)(4).(b)(4).

Manufacturer Narrative

Ref: (b)(4).Investigation: x- inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.Service & repair confirmed the complaint.This unit was found to have all its outputs running low.Given the age of the device wear and tear is potentially a root cause for this failure.Once the outputs were adjusted to specifications the unit operated normally.This unit was also noted to have the original diaphragm and updated accordingly.Previous issues with the diaphragm requires all units noted to have an original diaphragm will be updated whether they are faulty or not.The issue was due to a latex material degrading over time.A new material, silicone, was selected to replace it as it is not prone to losing its sealing function as did the latex version.A seal is needed for the pneumatic switch to turn on the power.Correction and/or corrective action: this unit was repaired, tested to specifications and returned to the customer.Concerning the diaphragm, sustaining engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No applicable correction available to train to.Was the complaint confirmed? yes.

• Brand Name: LEEP SYSTEM 1000 - 110V
• Type of Device: LEEP SYSTEM 1000
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8739407
• MDR Text Key: 149505721
• Report Number: 1216677-2019-00182
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other