MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO LINEAR CUTTERS ECHELON FLEX VASCULAR 35MM POWERED; STAPLE, IMPLANTABLE

Catalog Number PVE35A

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported that during an unknown procedure, the device sleeve was ripped off by competitor trocar.It is unknown what device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # p5682n.Device evaluation: the analysis found that one pve35a device was returned with the joint cover damaged and with one cartridge reload loaded on the device.The reload was received fully fired.The device was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.The damaged in the joint cover it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications.

• Brand Name: ENDO LINEAR CUTTERS ECHELON FLEX VASCULAR 35MM POWERED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 6883748
• MDR Text Key: 89271927
• Report Number: 3005075853-2017-05045
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Catalogue Number: PVE35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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