MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST GOLD RELOAD, 45MM, 6 ROW; STAPLE, IMPLANTABLE

Catalog Number GST45D

Device Problem Use of Device Problem (1670)

Patient Problems Failure to Anastomose (1028); Fistula (1862); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Date of event: publication year of 2019.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article?.

Event Description

It was reported via literature entitled: laparoscopic low anterior resection with two planned stapler fires.Author(s): koki otsuka, md, toshimoto kimura, md, teppei matsuo, md, hitoshi fujii, md, mizunori yaegashi, md, kei sato, md, suguru kondo, md, akira sasaki, md.Citation: jsls (2019); 23:1-6.Doi: 10.4293/jsls.2018.00112.Anastomotic leakage during laparoscopic low anterior resection (lap-lar) for rectal cancer remains challenging for colorectal surgeons.In this study, the authors describe a ¿double staple technique¿ (dst) procedure using 2 planned stapler fires in 272 patients with rectal cancer requiring lap-lars.Between november 2009 and september 2016, a total of 272 consecutive patients (163 male and 109 female; age range: 29¿89 years; mean bmi: 17.4¿40.3 kg/m2) underwent lap-lar with double-stapling anastomosis for rectal cancer.The rectal transections were performed intracorporeally with echelon flex 45-mm gold cartridge liner stapler (ethicon) through the 12-mm port in the right lower quadrant.End-to-end anastomosis was performed intracorporeally using a dst with a 25 cdh circular stapler (ethicon).Reported complications included anastomotic leakage (n-9) in which 5 patients had a diverting stoma and 4 patients required drainage only with no reoperation, and rectovaginal fistula (n-1) in which a diverting stoma was created the day after the event and closed the stoma after 8 months.In conclusion, rectal transection with 2 planned stapler fires appears safe, practical, and straightforward to standardize and reduces the need for multiple linear fires and the incidence of anastomotic leakage.

• Brand Name: GST GOLD RELOAD, 45MM, 6 ROW
• 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: 8695197
• MDR Text Key: 147873048
• Report Number: 3005075853-2019-19680
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014898
• UDI-Public: 10705036014898
• Combination Product (y/n): N
• PMA/PMN Number: K163454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GST45D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention