MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 23CM W ERG HANDLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	ACE23E
Health Effect - Clinical Codes	Swollen Lymph Nodes (2093); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event date unk.Medical device: 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.
Event or Problem Description
It was reported via journal article title: does ultrasonic energy for surgical dissection reduce the incidence of renal transplant lymphocele? author/s: e.W.Nelson, m.E.Gross, m.C.Mone, h.J.Hansen, x.Sheng, k.M.Cannon, and s.Alder.Citation: transplantation proceedings, 43, 3755¿3759 (2011), doi:10.1016/j.Transproceed.2011.08.079.This retrospective cohort study aimed to compare the rate of posttransplant lymphocele development using ultrasonic dissection (ud) versus a historic review of lymphatic control using suture ligation.From january 1994 to december 2009, records of a total of 532 patients who received transplants were reviewed.Within this population, 259 cases had suture ligation and 273 cases (n= 58.2% males, mean age: 39.9 years) employed the use of ud.The ud equipment used in this study was the harmonic ace shears with a length of 23 cm (ethicon) to control lymphatic vessels.Complaints included lymphocele (n=9.2%).Treatment could be either aspiration alone, initial percutaneous drainage with eventual surgical drainage, or surgical drainage without attempted prior treatment with percutaneous aspiration.There was no statistically advantage to the use of ud for lymphatic control, based on this experience there is an obvious advantage in terms of speed and convenience when using this type of dissection.As secondary endpoints of our data, we found that younger patients, those receiving living donor transplants, and those who had repeat transplantations were at a higher risk for development of lymphoceles after renal transplantation.

• Brand Name: HARMONIC ACE 23CM W ERG HANDLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9516453
• Report Number: 3005075853-2019-24746
• Device Sequence Number: 13986561
• Product Code: LFL
• UDI-Device Identifier: 10705036000891
• UDI-Public: 10705036000891
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ACE23E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention