MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 45 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number	EC45
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 7/3/2024.D4: batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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 mentioned in this article caused/contributed to the reported events in the article? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Title : a cooperative approach for treatment of zenker's diverticulum.Authors : daniel castaneda, francisco franco azar,ishtiaq hussain, luis f.Lara, ronnie r.Pimente,gilberto alemar,candace hrelec,jefrey ponsky, tolga erim citations : surgical endoscopy.Pages : 1-7.Https://doi.Org/10.1007/s00464-021-08736-z.The aim of this study was to evaluate the efficacy, failure rate, and safety profile of a cooperative approach by a gastroenterologist and otolaryngologist in the treatment of zenker¿s diverticulum.Single-center retrospective study of patients ( n=63 ) who underwent a cooperative endoscopic diverticulectomy by a gastroenterologist and otolaryngologist at cleveland clinic florida between 2012 and 2019.Patients were predominantly males (63.5%) and white (84.1%), with mean age 73.5 years (53¿95).Most subjects presented dysphagia (98.4%), mostly to solids (79.4%).An endopath 45 stapler (ethicon endo-surgery, cincinnati, oh, usa) was engaged onto the muscular bar and subsequently fired.If no muscular bar division was achieved, a harmonic endoscopic scalpel was used to cut the tissue or endopath scissors were used to cut the midline of the stapler and a second stapling pass was performed as mentioned before.In conclusion, a cooperative endoscopic approach by gastroenterology and otolaryngology for symptomatic zenker¿s diverticulum management offered excellent technical and clinical success.This approach proved to be safe and effect.

• Brand Name: ECHELON 45 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19666545
• Report Number: 3005075853-2024-04897
• Device Sequence Number: 6823063
• Product Code: GDW
• UDI-Device Identifier: 10705036001669
• UDI-Public: 10705036001669
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EC45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown