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

Catalog Number ACEXXX

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

Patient Problems Fistula (1862); Nausea (1970); Discomfort (2330); Abdominal Distention (2601); No Code Available (3191)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2010.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.

Event Description

Title : ureteral injury due to a harmonic scalpel during laparoscopic salpingo-oophorectomy.Author : patrick f.Vetere, md, costas apostolis, md.Citation: jsls (2010)14:115¿119 / doi: 10.4293/108680810x12674612014987.The purpose of this case report is to demonstrate the unusual complication of a ureteral injury with the harmonic scalpel (hs) during a bilateral laparoscopic salpingo-oophorectomy.This is concerning a (b)(6)-year-old, g0p0, perimenopausal female who was admitted in oct 2007 for an enlarging, complex right adnexal mass measuring 4cm in size.The patient was then admitted for probable laparoscopic bilateral salpingo-oophorectomy, possible hysterectomy.The right adnexum contained a 4-cm, nontender, mobile mass.Intraoperative findings revealed a 4-cm to 5-cm probable endometrioma of the right ovary that was remarkably free of adhesions and small subserosal uterine myomas.There were dense adhesions of cul de sac peritoneum to the posterior lower uterine segment.The left tube and ovary were densely adherent to the pelvic sidewall just above the ureter, to the posterior broad ligament and to the upper half of the left side of the uterus.Patient¿s thin retroperitoneum and 5-cm to 6-cm below, the right infundibulopelvic ligament was coagulated and divided without difficulty utilizing the harmonic scalpel (ethicon) at power level 3.The right tube and ovary were then removed also with the harmonic by coagulating and dividing its remaining attachments to the uterus.Because of the dense adhesions of the fibrotic left tube and ovary, the left pelvic sidewall was opened to allow identification of the ureter on that side.It was found to be adherent to the ovarian vessels for several centimeters along the left infundibulopelvic ligament.Using cold scissors and the harmonic scalpel (hs), we freed the ureter with some difficulty from the vessels so that they could be coagulated and divided with the harmonic scalpel.The patient was seen on postoperative day 3 complaining of bloating and abdominal discomfort.Examination revealed minimal abdominal distension.The patient was seen 10 days later.At that time, she complained of nausea relieved by food and was now taking prilosec.She also noted that she had been having increased bloating and abdominal discomfort for several days.The patient saw her gastroenterologist 10 days later because of abdominal distension.Ct demonstrated a large amount of abdominal fluid with normal-appearing liver and kidneys.The retrograde pyelogram on the right side, however, revealed a ureteral fistula at the level of s-1.A j-stent was placed and the patient was discharged.Approximately 2 months subsequently, the stent was removed and the fistula had healed.A degree of stenosis secondary to scarring was found and dilated.A second j stent was placed and was removed approximately 6 weeks to 8 weeks later with acceptable patency of the ureter at that time.This case raises issues that should caution surgeons who utilize this instrument to pay particular attention to application times during dissection.This is particularly true of dissection of peritoneum at high power settings (level 4 and 5) during which tissue may fail to divide at the proximal portion of the blades while allowing contact between the distal blade ends.The rapid rise in temperature that would occur under those conditions could result in unexpected thermal injury in adjacent structures.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9491235
• MDR Text Key: 188845238
• Report Number: 3005075853-2019-24523
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1