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

Catalog Number LCSXX

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

Patient Problems Fever (1858); Hemostasis (1895); Inflammation (1932); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2006.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: laparoscopic surgical staging for uterine malignancies using harmonic shears (ultracision) in comparison to electrosurgery: operative technique, feasibility and complications.Author(s): zdenek holub, antonin jabor.Citation: gynecol surg (2006) 3: 25¿30; doi 10.1007/s10397-005-0173-x.The purpose of this retrospective comparative clinical study was to assess the ultrasonic operative technique, feasibility and complications in a large group of patients laparoscopically staged for endometrial or cervical cancer.Between apr1996 and may2005, 119 female patients with uterine cancer underwent laparoscopic assisted vaginal hysterectomy (lavh), total laparoscopic hysterectomy (tlh) or radical laparoscopic assisted vaginal hysterectomy (ralvh) plus bilateral salpingo-oophorectomy (bso) and/or lymph node dissection (lnd) during a primary surgical procedure using an electrosurgery (elc, n=37; age of 54.5 years [sd±10.3]) or ultrasonic (us, n=82; age of 56.6 years [sd±7.4]).In the us group, the harmonic scalpel and shears (lcs-k5 or lcs-c; ultracision; ethicon endosurgery, johnson & johnson, cincinnati, oh, usa) were applied at power levels from 1 to 5 (full power).In one case under us group, bladder injury occurred requiring suture via laparotomy at the end of the laparoscopic procedure.In two patients under the us group, prompt and through hemostasis was unable to perform because of ineffective post-ultrasonic coagulation of venous paravaginal varices (ralvh) and of vena ovarica varices (lavh, bso procedure).Minor complications in us group included postoperative fever (n=1), and signs of inflammation and edema of the obsturator nerve (n=1) but subsided after anti-inflammatory and electro-stimulative covalescence therapy.The ultracision operative technique ensures efficient dissection, coagulation, cutting, and grasping for lass in women with cervical and endometrial cancer.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9613457
• MDR Text Key: 183511302
• Report Number: 3005075853-2020-00496
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other