MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 12/01/2021

Event Type  Death  

Event Description

Title: learning curve from 450 cases of robot-assisted pancreaticoduocectomy in a high-volume pancreatic center optimization of operative procedure and a retrospective study author(s): yusheng shi, md, weishen wang, md, weihua qiu, md, phd, shulin zhao, md, jian wang, md, yuanchi weng, md, zhen huo, md, jiabin jin, md,yue wang, md, xiaxing deng, md, phd, baiyong shen, md, phd, and chenghong peng, md, phd citation: ann surg 2021;274:e1277¿e1; doi: 10.1097/sla.0000000000003664 this study aimed to describe our experience and the learning curve of 450 cases of robot-assisted pancreaticoduodenectomy and optimize the surgical process so that our findings can be useful for surgeons starting to perform robot-assisted pancreaticoduodenectomy.Between may 2010 and december 2018, 450 patients who underwent robot-assisted pancreaticoduodenectomy were included in the study.There were 249 males and 201 females with a mean age of 57.9 years and a mean bmi of 23.1 kg/m2.During the procedure, gastrectomy was performed using a non-ethicon surgical stapler (manufacturer: unknown).The uncinate process was separated upwardly by the harmonic scalpel (ethicon endo-surgery).Reconstruction of the pancreatic remnant: pancreaticojejunostomy was performed as end-to-side duct-to-mucosa reconstruction.3¿0 prolene suture (ethicon) was chosen for the outer layer.6¿0 or 5¿0 prolene suture (ethicon) was used for the inner layer according to the size of mpd.Reconstruction of cholangiojejunostomy was performed with 5-0 prolene suture (ethicon) or non- ethicon polydioxanone continuous sutures (manufacturer: unknown).For those having strong tension of cholangiojejunostomy, several sutures were added nearby to reduce the tension.Reconstruction of the gastrojejunostomy was usually performed using a competitors¿ suture (manufacturer: medtronic) inside the abdomen.Otherwise, the stomach and the jejunum were anchored together, then the gastrojejunostomy was performed outside the abdomen using a competitors¿ suture (manufacturer: medtronic) or a non-ethicon stapler (manufacturer: unknown).Reported complications included massive bleeding (n=3), biochemical/bile leak (n=39), postoperative pancreatic fistulas (n=44), postoperative abdominal bleeding (n=13), postoperative bleeding (n=10), unspecified severe complications/clavien-dindo class iii or higher (n=32), death due to abdominal bleeding caused by postoperative pancreatic fistulas and infection (n=4).In conclusion, robot-assisted pancreaticoduodenectomy is safe and feasible for selected patients.Operative and oncologic outcomes were much improved after experience of 250 cases.Our optimization of the surgical process may have also contributed to this.Future prospective and randomized studies are needed to confirm our results.

Manufacturer Narrative

(b)(4).Date sent: 2/23/2024 b3: publication year of 2021 d4: batch # unk this report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon harmonic device caused or contributed to the patient complications mentioned in the article? if yes, please explain does the author/surgeon believe that the ethicon harmonic device caused or contributed to the patient death mentioned in the article? if yes, please explain is the author/surgeon interested in speaking with ethicon medical and engineering? the author could not be contacted and the information could not be confirmed.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.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 18767432
• MDR Text Key: 336111715
• Report Number: 3005075853-2024-01579
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death