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

Model Number L1000

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

Ref: (b)(4).While cutting and cauterizing then stop.Unit would beep when paused but nothing would happen.After 10 minutes or so would work again.Order: (b)(4).Leep system 1000 - 110v l1000 (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 4/25/2000 under wo #8408 and shipped 2000.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: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 95204.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: unit was functioning properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.No root cause is applicable.Corrective actions relevant to the updated diaphragm are as follows; the diaphragm was changed out due to a previous finding where the material degraded to the point where it no longer functioned as intended and prevents activation of a unit.This unit's diaphragm was in working order.However, the corrective action for this issue requires returned units be updated to the new material and applicable on this unit.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.Corrective actions relevant to the updated diaphragm are as follows; coopersurgical service and repair replaced the diaphragm on the unit, tested it 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.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Ref: e-complaint (b)(4).While cutting and cauterizing then stop.Unit would beep when paused but nothing would happen.After 10 minutes or so would work again.Order: 95204 1216677-2020-00280 leep system 1000 - 110v l1000 e-complaint (b)(4).

• Brand Name: LEEP SYSTEM 1000 - 110V
• Type of Device: LEEP SYSTEM 1000
• 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: 10922968
• MDR Text Key: 219360353
• Report Number: 1216677-2020-00280
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• 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