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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Electrolyte Imbalance (2196); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.(b)(4).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 device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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 Description

Title: acute kidney injury following hepatectomy and its impact on long-term survival for patients with hepatocellular carcinoma.Author: k.F.Lee *, e.Y.J.Lo, k.K.C.Wong, a.K.Y.Fung, c.C.N.Chong , j.Wong, k.K.C.Ng and p.B.S.Lai.Citation: bjs open, 2021, zrab077 doi: 10.1093/bjsopen/zrab077.This prospective study aims to identify factors predicting the occurrence of acute kidney injury (aki) after hepatectomy and its clinical impact, as well as the impact on long-term outcome of patients with hepatocellular carcinoma (hcc).Between september 2007 and december 2018, 930 patients underwent partial hepatectomy in this centre.Of these, 560 (478 males and 82 females) had histologically proven hepatocellular carcinoma (hcc).Hepatectomy was carried out by different approaches according to indication and feasibility, including open, laparoscopic and robotic techniques.Robotic hepatectomy was performed with the da vinci robot s or xi system (intuitive, sunnyvale, ca, usa).Liver was transected with robotic harmonic acetm (ethicon endo-surgery, cincinatti, oh, usa) and tissuelinktm.Reported complications included: intraoperative adverse events ,sustained systolic bp below 90mmhg for more than 20 min: (n=14) with acute kidney injury (aki) and (n=87) without acute kidney injury (aki).Blood loss (ml)* > 378 : (n=45) with acute kidney injury (aki) and (n=196) without acute kidney injury (aki), where 14 and 45 had blood transfusion , respectively.The incidence of acute kidney injury (aki) was 9.2 per cent.The distribution of patients by grade of acute kidney injury (aki) was: (n=60) patients in stage 1, (n=19) patients in stage 2, and (n=7) patients in stage 3.Six patients needed renal replacement therapy as a result of acute kidney injury (aki).Clavien¿dindo grade of complication: grade i (n=44), grade ii (n=54) , grade iii (n=48) , grade iv (n=5) and grade v (n=7).90-day mortality 9 (with acute kidney injury (aki) , and 90-day mortality 6 (died in the hospital) with (with acute kidney injury (aki).(n=10) phlf posthepatectomy liver failure.It was concluded , that acute kidney injury (aki) is associated with longer hospital stay, and higher morbidity and mortality rates.It is also associated with shorter long-term survival among patients with hepatocellular carcinoma (hcc).To avoid acute kidney injury (aki), control of blood loss and maintaining a reasonable bp (72¿77 mmhg) during hepatectomy is important.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15401403
• MDR Text Key: 299673416
• Report Number: 3005075853-2022-05940
• 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: 09/12/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention