MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN

Model Number 52969

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

This device was sent in for pm and evaluation of diaphragm.Order: (b)(4).Verified--replaced diaphgram and front case mod.Re-adjust output power.Leep system 1000 esu gen 52969 e-complaint-(b)(4).

Event Description

This device was sent in for pm and evaluation of diaphragm.Order: (b)(4).-verified--replaced diaphgram and front case mod.Re-adjust output power.1216677-2021-00228 leep system 1000 esu gen 52969 e-complaint-(b)(4).

Manufacturer Narrative

Investigation x-inspect returned samples *analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 09/18/2003 under wo #(b)(4) and shipped on 11/06/2003.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was returned on a repair log 97040.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the complaint is considered confirmed due to the unit being sent for pm.This unit was 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 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, p/n 35387b.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.Correction activity in 2016.*preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP SYSTEM 1000 ESU GEN
• Type of Device: LEEP SYSTEM 1000 ESU GEN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12616467
• MDR Text Key: 278086447
• Report Number: 1216677-2021-00228
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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