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

Model Number L1000

Device Problem Energy Output Problem (1431)

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

Event Date 01/10/2020

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.Ref (b)(4).

Event Description

Customer stated "stops during procedure until pedal is unscrewed and screwed back".Reference repair order #: (b)(4).

Event Description

Customer stated "stops during procedure until pedal is unscrewed and screwed back" reference repair order #(b)(4).E-complaint-(b)(4).

Manufacturer Narrative

Investigation : x-inspect returned samples.*analysis and findings: complaint #(b)(4).Distribution history: this complaint unit was shipped on 6/25/2003.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at this time.However, at the time of manufacture, records from each unit are reviewed to ensure that product meet all specifications.Should the device history record be located, this complaint will be amended accordingly.Incoming inspection review: n/a.Service history record: the unit was in for a bad diaphragm in march 2013 under log (b)(4).Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair.However, based on log (b)(4), this unit was at csi on 1/16/2020.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: unit was not functioning properly.Root cause: the diaphragm is the mechanism to make contact (for electrical current) to supply power to the unit.Air displacement pushes on a piston via the diaphragm into a switch to turn the power on.The foot pedal creates the air displacement to the pneumatic switch mechanism located in the housing of the unit.The diaphragm breaks down and loses its seal and cannot function properly.The diaphragm is described as a rubber, possibly a latex.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Materials like latex are flexible hence the use in this application, but its' elastic properties can alter over time as well.The root cause for this complaint condition is component related to the diaphragm.*correction and/or corrective action.Coopersurgical service and repair replaced the diaphragm on the unit and returned it to the customer.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.

• 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: 9673134
• MDR Text Key: 191402900
• Report Number: 1216677-2020-00030
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other