MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ULTRACISION HARMONIC FOCUS; SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Perforation (2001); Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2022.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.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.What were the causes of the patients deaths? does the author/surgeon believe that the ethicon device caused or contributed to the patients deaths (n=2) mentioned in the article? if yes, please explain was there an alleged deficiency or malfunction with the device that caused or contributed to the deaths? a request for medical opinion was sent to the medical safety officer and his review is below: 1.In the article, it says ¿the mesentery incision is performed using the harmonic focus_ long shears (ethicon endo-surgery inc., cincinnati, oh, usa) or the ligasuretm maryland jaw (covidien, mansfield, ma, usa).¿ so it is clear where our energy device was used in the procedure.2.Two patients died from early postoperative complications: one was from acute myocardial infarction (1) and another was from dehiscence of ileal anastomosis + severe atrial fibrillation (1) (see table 2 grade v).The causes of the patients¿ deaths were not related to the mesentery incision where harmonic focus long was used.Therefore, there is no relationship between the patients¿ death and our device use.

Event Description

Title: retrosigmoid ileal conduit without transposition of the left ureter after open radical cystectomy for bladder cancer.Authors: vincenzo ficarra1, alessandro crestani2 , marta rossanese1, giuseppe alario1, giuseppe mucciardi1, gianluca giannarini3 and claudio valotto3.Citation: bju int 2022; 129: 48¿53.Doi:10.1111/bju.15375.The aim of this study is to assess perioperative outcomes, complications, and rate of uretero¿ileal anastomotic stricture (uas) in patients undergoing retrosigmoid ileal conduit after radical cystectomy (rc).A total of 97 patients (81 male and 16 female; median age of 75 (68¿78) years; median bmi of 26 (23¿29.4) kg/m2) receiving retrosigmoid ileal conduit after open radical cystectomy for bladder cancer between march 2016 and june 2020 at two academic centres were prospectively collected.Briefly, ~20 cm proximal to the ileocecal valve, a 20-cm long ileal segment is isolated.While the incision of the mesentery at the level of the distal end of the selected ileal segment is straight, the incision of the mesentery at the level of the proximal end is longer, and directed in an oblique plane in order to accommodate its retrosigmoid passage with no tension.The mesentery incision is performed using the harmonic focus® long shears (ethicon endo-surgery inc., cincinnati, oh, usa) or the ligasure¿ maryland jaw (covidien, mansfield, ma, usa).A side-to-side ileo¿ileal anastomosis is made using gia¿ 80-mm and ta¿ 60-mm (covidien) staplers.The mesentery window is closed with interrupted sutures.The proximal end of the ileal segment is closed with ta¿ 30-mm (covidien) stapler, passed through a wide, bluntly dissected, retrosigmoid tunnel from the right to the left body side, and fixed to the psoas muscle tendon with two or three interrupted 3-0 polyglactin 910 sutures (vicryl®; endo-surgery inc.).The redundant tract of the left distal ureter is resected in order to obtain a tension-free uretero¿ileal anastomosis without kinking, and the ureter is anastomosed to the anterior face of the proximal portion of the ileal segment.The right ureter is anastomosed to the most caudal point of the right distal portion of the ileal segment.Both uretero¿ileal anastomoses are made with four interrupted polyglactin 910 sutures over a 6-f ureteric catheter according to the standard direct end-to-side nesbit technique [12], and are covered by the posterior peritoneum so as to minimise any risk of anastomotic leakage of urine, if any, into the peritoneal cavity.Finally, an abdominal nipple stoma in the right iliac fossa is made.Reported complications include death (n=2) from early postoperative complications within 3 months of surgery; unknown event requiring intraoperative blood transfusion (n=15); postoperative anaemia (n=9) requiring blood transfusions; ileus (n=1) requiring parenteral nutrition; small bowel obstruction (n=2) which required lyse of ileal adhesions/ileal resection; postoperative bleeding (n=1) requiring surgical revision with haemostasis; sepsis (n=1) requiring intravenous antimicrobials + icu management; small bowel perforation (n=1) requiring ileal resection + icu management.In conclusion, the retrosigmoid ileal conduit is a safe and valid option for non-continent urinary diversion after rc, ensuring a very low risk of uas at an intermediate-term follow-up.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE
• 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: 15406736
• MDR Text Key: 299757484
• Report Number: 3005075853-2022-05993
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: UNK_ULTRACISION HARMONIC FOCUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention