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

Catalog Number ACEXXX

Device Problems Leak/Splash (1354); Failure to Form Staple (2579)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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 surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

It was reported in journal article title: comparison of mini-gastric bypass with sleeve gastrectomy in a mainly super-obese patient group: first results.Authors: andreas plamper, philipp lingohr, jennifer nadal, karl p.Rheinwalt.Citation: surgical endoscopy (2017); 31:1156¿1162.Doi: 10.1007/s00464-016-5085-5.The authors evaluated the data on both sleeve gastrectomy (sg) and mini-gastric bypass procedure (mgb) which they used in mainly super-obese patients, and presented their early postoperative and perioperative outcome.In an observation period from august 2007 until march 2015, a total of 287 patients were identified and included in the study: 169 patients (48 male and 121 female; mean age: 43.2±11.1 years; bmi: 54.1±6.6 kg/m2) underwent mgb as a primary procedure (mgb-group), while 118 patients (46 male and 72 female; mean age: 43.4±11.2 years; bmi: 54.6±10.3 kg/m2) were operated by sg (sg-group).In mgb technique, the gastric pouch was created by starting dissection with harmonic ace ultrasonic scissors (ethicon) 3 cm below the crow¿s foot on the lesser gastric curvature.Gastric division was then performed by powered echelon flex, 60-mm cartridges linear stapler (ethicon) against a 30-french bougie placed on the lesser curvature side and completed all the way up to the visualized angle of his.In sg technique, the greater curvature was dissected by harmonic ace ultrasonic scissors (ethicon) beginning 3¿5 cm above the pylorus all the way up to the angle of his.A 36-french bougie was then placed in the stomach by the anaesthesiologist before gastric sectioning was performed by means of a powered echelon flex, 60-mm cartridges linear stapler (ethicon).Reported complications in the mgb-group included leakage (n-1), hemorrhage (n-2), incarcerated incisional hernia (n-1), others (n-1), and combined acid/biliary reflux (n-1) in which the patient had to be converted to roux-en-y gastric bypass (rygb).In sg-group, reported complications included leakage (n-6), hemorrhage (n-1), incarcerated incisional hernia (n-1), mesenterial ischemia (n-1), others (n-1), and new onset of gastroesophageal reflux disease (gerd) (n-1) and combined dysphagia/gerd (n-2) in which the patients had to be re-operated and converted to rygb.Also in the mgb-group, one patient died of late multiorgan failure after postoperative hemorrhage more than 30 days after mgb.In sg-group, one patient died within 30 days after operation due to multiorgan failure after staple line leakage.In conclusion, mgb achieved superior weight loss at 1 year and had a lower 30-day complication rate in comparison with sg for super-obese patients.Thus, mgb might be superior to sg regarding the treatment of super-obesity.

• Brand Name: ULTRACISION HARMONIC ACE (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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8692830
• MDR Text Key: 147794887
• Report Number: 3005075853-2019-19670
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K051036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• 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: 06/12/2019
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death