MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number LCSXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

Title : initial experience from a large referral center with robotic-assisted ivor lewis esophagogastrectomy for oncologic purposes author : sebastian g.De la fuente ¿ jill weber ¿ sarah e.Hoffe ¿ ravi shridhar ¿ richard karl ¿ kenneth l.Meredith.Citation: surg endosc.2013; 27: 3339¿3347.Doi: 10.1007/s00464-013-2915-6.The authors reported the initial experience of patients undergoing robotic-assisted ivor lewis esophagogastrectomy (rail) for oncologic purposes at a large-referral center.This is a retrospective review of all 50 consecutive patients (age range: 42 to 82 years old; 39 male and 11 female patients; bmi: 28.6 ± 0.7) undergoing rail from 2010 to 2011.During the surgical procedure, posterior pancreaticogastric attachments are taken down with the harmonic scalpel (ethicon).The dissection is carried along the greater curvature of the stomach, up to the level of the short gastric vessels, which are taken with the harmonic scalpel (ethicon) to the level of the left crus of the diagram and carried circumferentially over to the right.A 4-cm-wide gastric conduit is then created with several fires of an echelon stapler (ethicon).Reported complications included anastomotic leak (n-1), conduit staple line leak (n-1), and chyle leak (n-2).This study represents the first report to our knowledge of rail.Esophagogastrectomies for esophageal cancer in elderly overweight patients and the largest series to date.Despite the steep learning curve associated with these procedures, the initial experience demonstrates acceptable complication rates, hospital stays, and lymph nodes harvested comparable to other techniques.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9359249
• MDR Text Key: 185063769
• Report Number: 3005075853-2019-23678
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other