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

Model Number KH1000

Device Problem Failure to Cut (2587)

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

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported condition.Once the investigation is completed a follow-up report will be filed.Ref e-complaint (b)(4).

Event Description

Customer stated "not heating/cutting properly." ref e-complaint (b)(4).

Manufacturer Narrative

Investigation x-inspect returned samples *analysis and findings complaint #2019-12-0000139 distribution history: this complaint unit was manufactured at csi on 8/9/13 under wo #150585 and shipped on 8/13/13.Manufacturing record review: dhr 150585 was reviewed and no non-conformities, related to the complaint condition, were noted.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 no similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log 93108.Visual evaluation: visual examination of the complaint unit revealed physical damage.The damage was significant to the bottom case.The ac plug was was out of the generator, the ac socket was cracked, the strain relief was cracked, and loose & missing hardware was noted.Functional evaluation: unit was not functioning properly.Root cause: due to the damage a root cause is not readily available.The units' condition is considered suspect and possibly related to the problem description.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 the unit was repaired, tested to specifications and returned to the customer.Coopersurgical service and repair team 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.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Customer stated "not heating/cutting properly" ref e-complaint-2019-12-0000139.

• Brand Name: LEEP SYSTEM 1000 WORKSTN
• Type of Device: LEEP SYSTEM 1000 WORKSTN
• 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: 9503455
• MDR Text Key: 190550744
• Report Number: 1216677-2019-00319
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483 DISC
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KH1000
• Device Catalogue Number: KH1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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