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

Model Number 52969

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Sent in for eval.No paperwork sent in.Order: (b)(4).Replaced foot p., bottom case & diaphram.Leep system 1000 esu gen 52969 e-complaint (b)(4).

Manufacturer Narrative

Investigation: x-inspect returned samples.*analysis and findings: (b)(4).Distribution history: this complaint unit was manufactured at csi on 09/14/2001 under wo #(b)(4) and shipped on 09/26/2001.Manufacturing record review: a review of the device history record could not be performed at the time of this investigation.However, records from each lot are thoroughly reviewed to ensure products are released meeting quality release specifications.Should the device history record be located this complaint will be 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.The complaint was not confirmed.Product receipt: the complaint unit was returned on repair log 95166.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the units' foot pedal was no good and the guide pins were broken off the case.Root cause: root cause is being attributed to end user handling error.Also, given the age of the device the foot pedal failure is being attributed to normal wear and tear.Note: this unit was not returned with a specific complaint condition.In regard to the diaphragm: 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 this unit was repaired, tested to specifications and returned to the customer.No further corrective action is necessary.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, (b)(4).The ifu was also updated to add a safety check via (b)(4).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.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Sent in for eval.No paperwork sent in.Order: (b)(4).Replaced foot p., bottom case & diaphram.Leep system 1000 esu gen 52969 (b)(4).

• 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: 11006360
• MDR Text Key: 242904992
• Report Number: 1216677-2020-00301
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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
• Date Manufacturer Received: 11/15/2020
• 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