MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number SC45A

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 5/12/2017.Batch # n56y1t.Additional information was requested and the following was obtained: what type of procedure was the device used in? thoracic lobectomy (vats) just for clarification, did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? the device deploy staples but the stapling could not be completed.What color cartridge was being used? green reload the analysis found that the sc45a device was received with no apparent damage and without a reload present.The device was tested for functionality in the articulated position with a test cartridge reload and it fired, and formed all the staples as intended.The cut was noted to be jagged due to a damaged knife.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, during firing the track of stapling sometimes got stuck and the surgeon needed to reverse the blade and change new reloads.They encountered this problems three times and then changed to another new gun to complete procedure.There were no adverse consequences for the patient.

• Brand Name: ENDO LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6563044
• MDR Text Key: 75151088
• Report Number: 3005075853-2017-02535
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Catalogue Number: SC45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELOAD - ECR45G