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

Catalog Number EC45AL

Device Problems Defective Component (2292); Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: can you please clarify what was meant by, after testing the material doesn¿t return to run? the echelon flex product (ec45al) did not make the formation clipping of the tissue.Due to this reason, the doctor had to open other material to complete the surgery.The complaint form indicated this was a potential adverse event and that intervention was required to prevent permanent impairment or damage.Was any intervention required other than intra-operative suturing (over-suture)? the surgeon made oversuture throughout all the staple line in the region of the three first staples, where the clip has not formed, he oversutured 2 times.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 bariatric sleeve procedure, the surgeon makes contact with us.The doctor said the clips don't form.He stapled two green recharges and one golden recharge.Later he changed the stapler and used three more blue recharges.He made over suture throughout the staple line at the region of the first three staples, where the clip doesn't form, he over sutured two times, yet, at the beginning of surgery, the instrument began presenting defects, after testing the material doesn't return to run.The device didn't make the staple line.The surgeon had to open another material, because it was at the beginning of the surgery and it was of extremely necessary to use the material.

Manufacturer Narrative

(b)(4).The analysis found that one ec45al device was returned with no apparent damage and with no cartridge reload present.The device was tested for functionality in the articulated 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 event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ECHELON FLEX 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: 6013531
• MDR Text Key: 57344942
• Report Number: 3005075853-2016-05815
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051002
• 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,Followup
• Report Date: 09/23/2016

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: 02/28/2019
• Device Catalogue Number: EC45AL
• Device Lot Number: N90T7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELOAD - ECR45D, ECR45G, ECR45B