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

Catalog Number LCSXX

Device Problem Overheating of Device (1437)

Patient Problems Bowel Perforation (2668); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

Title: electrothermal bipolar vessel sealing device vs.Ultrasonic coagulating shears in laparoscopic colectomies: a comparative study.Authors: roberto campagnacci, angelo de sanctis, maddalena baldarelli, massimiliano rimini, giovanni lezoche, mario guerrieri.Citation: surg endosc.2007; 21: 1526¿1531.Doi: 10.1007/s00464-006-9143-2.Many devices are available for vascular control during laparoscopic colorectal procedures.Ultrasonic coagulating shears (ucs), vascular staplers, titanium or plastic clips, and electro thermal bipolar vessel sealing (ebvs) are currently used according to the surgeon s preference.This study aimed to compare ebvs ligasure with ucs.The authors reported the outcome of 200 consecutive patients who underwent laparoscopic colorectal resections of which 100 patients (51 male and 49 female patients; age range: 36 to 93 years old; bmi: 25 to 38) were performed with ebvs ligasure (from september 2004 to december 2005; group 1) and 100 patients (59 male and 41 female patients; age range: 39 to 88 years old; bmi: 24 to 37) with ucs harmonic scalpel (ethicon; from december 2002 to june 2004; group 2).With respect to resections for malignancy, oncologic criteria have been the main landmarks in both groups: lymph node clearance, depending on both level of vessel section and width of mesocolon dissection, and total mesorectal excision (tme) in rectal procedures.In group 2, reported complications included a (b)(6)-year-old female patient with abdominal pain, bile leakage through the abdominal drain; surgical exploration found a duodenal fistula near the origin of the right colonic vessel which required reoperation.Review of the videotape of the operation allowed the authors to see that during vessel dissection by ucs, a duodenal serosa white ischemic lesion resulted from the overheated active blade of the ucs touching the duodenal wall.A (b)(6)-year-old female patient with intraoperatively undetected ileal microperforation, most likely originating from surgical manipulation by the ucs device during right laparoscopic colectomy which required reoperation.In the laparoscopic colorectal experience, ebvs ligasure has proven safe and effective in vessel sealing.Patients in whom this device was used had less blood loss and slight advantages in operating time and postoperative hospital stay.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9288327
• MDR Text Key: 165559565
• Report Number: 3005075853-2019-23287
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention