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

Catalog Number ACEXXX

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

Patient Problems Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2022.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 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: effect of infrahepatic inferior vena cava partial clamping on central venous pressure and intraoperative blood loss during laparoscopic hepatectomy authors: lin-kang xiao1 · pan huang2 · kun wu1 · ji-feng xiang1 · xiang fu1 · ming-you zheng1 · xiao-xue song1 · wei xie1 citation: surgical endoscopy (2021) 35:2773¿2780.Https://doi.Org/10.1007/s00464-020-07709-y the aim of this retrospective study is to evaluate its efficacy and safety during laparoscopic hepatectomy (lh).Between september 2014 to august 2019, a total of 132 patients who underwent lh were included in this study.68 patients (37 male and 31 female; mean age of 56.8 ± 9.3 years) were allocated to infrahepatic ivc clamping group and 64 patients (34 male and 30 female; mean age of 57.2 ± 8.9 years) to non-clamping group.The parenchymal transection was performed using harmonic ace.Reported complications include unknown event requiring intraoperative transfusion (n=17), ascites (n=11), pleural effusion (n=15), and bile leakage (n=3).In conclusion, these data suggest that infrahepatic ivc clamping may be safe and effective.

• 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 ; * 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: 15401191
• MDR Text Key: 299668827
• Report Number: 3005075853-2022-05939
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051036
• 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

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• 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