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

Model Number 52969

Device Problem Output below Specifications (3004)

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

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported condition.

Event Description

Customer stated "low output".Reference repair order #: (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 8/17/2005 under wo #(b)(4) and shipped on 08/24/2005.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 a repair.However, based on log 93909, this unit was at csi on 2/19/2020.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Updated component: 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.No further corrective action is necessary, as the complaint condition was not confirmed.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.Preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Customer stated "low output" reference repair order #(b)(4).(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
• MDR Report Key: 9771125
• MDR Text Key: 191403578
• Report Number: 1216677-2020-00069
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483DISCO
• 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: 05/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other