MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX ENDOCUTTER; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 7/13/2016.Batch # unk the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: can you please explain how the device was defective? after stapling, it was impossible to open the device.The device was finally removed but the stapling was incomplete.Another device was used to complete the procedure successfully.What caused the bleeding? incomplete stapling.How was the bleeding controlled? another device was used.How much blood was lost (ml)? unknown.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? no.

Event Description

It was reported that during a nephrectomy procedure, the device was defective.Management of the issue at the time of maximum risk after clamping of the renal pedicle.Controlled bleeding.No further information is available.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: ECHELON FLEX ENDOCUTTER
• 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: 5792076
• MDR Text Key: 50104111
• Report Number: 3005075853-2016-03943
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: EC60A
• Device Lot Number: N9173U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1