MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/GRN RLD; STAPLE, IMPLANTABLE

Catalog Number	ATG45
Health Effect - Clinical Codes	Abscess (1690); Hematoma (1884); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent: 11/3/2019.Date of event: publication year of 2015.Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon devices caused or contributed to the patient complications mentioned in the article? if yes, please explain.(b)(4).
Event or Problem Description
It was reported via literature entitled: single-incision laparoscopic surgery for rectal cancer: early results and medium-term oncological outcome.Author/s: k.Gash, m.Bicsak and a.Dixon.Citation: colorectal disease 2015 the association of coloproctology of great britain and ireland.17, 1071¿1078; doi:10.1111/codi.13034.This prospective electronic database study aimed to report the medium-term oncological outcome from a prospective observational study of single-incision laparoscopic surgery (sils) for rectal cancer undergoing high and low anterior resection.Between 2009 and 2014, 61 patients with rectal cancer underwent sils by high anterior resection (n=34), lower anterior with total mesorectal incision[tme] (n=24), and low anterior resection with tme and hand-sewn anastomosis (n=3).During colonic mobilization, dissection commenced inferior and medial to an elevated inferior mesenteric artery using a harmonic ace scalpel (ethicon) and high division of vein and artery was completed using the instrument.The rectum was then divided distal to the tumour in an anteroposterior direction using atg45 (ethicon endocutter) one or two staple firings.During anastomosis, an end-to-end colo-anal anastomosis was completed using a cdh29 (cdh29, ethicon endo-surgery inc.).Early and late complications included anastomotic bleeding (n=2), haematoma formation (n=2), wound infection (n=1) and intraperitoneal abscess (n=1).Patients were managed conservatively.Anterior resection with tme for rectal cancer can be safely performed using the sils technique, with acceptable histopathological results and good oncological outcome.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon devices caused or contributed to the patient complications mentioned in the article? if yes, please explain.Response received: i don't think i can blame your product! just one of those things.Upon review of the information provided by the author that the ethicon products are not to blame for the patient complications described in the article, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: 45MM ARTICNG LNR CUTR/GRN RLD
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9294928
• Report Number: 3005075853-2019-23347
• Device Sequence Number: 607521
• Product Code: GDW
• UDI-Device Identifier: 10705036001065
• UDI-Public: 10705036001065
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ATG45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention