MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number LCSXX

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

Patient Problems Fistula (1862); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/23/2019.Batch # unk.Date of event: publication year for the journal article is 2011.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

It was reported that during a review of a journal article, title: the outcome of laparoscopic radical hysterectomy (lrh) and pelvic lymphadenectomy in patients with early invasive cervical cancer.Author/s: jihad d.; fritz j.Citation: gynecol surg (2011) 8 (suppl 1):s185.Doi 10.1007/s10397-011-0694-4.The aim of this study was to evaluate retrospectively feasibility and oncological outcome of laparoscopic radical hysterectomy (lrh) in patients with ib1 stage cervical cancer.This retrospective study involves 50 patients with cervical cancer (stage ib1) and were treated with lrh and pelvic lymphadenectomy.The radical hysterectomy was performed using the harmonic scalpel (ethicon).Reported complication included postoperative bleeding (n-1) which needed a second surgery, and ureterovaginal fistula after the operation (n-1).In conclusion, the lrh is feasible with excellent surgical and oncological outcome which is comparable to patients treated with laparotomy.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 9511141
• MDR Text Key: 189084584
• Report Number: 3005075853-2019-24736
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention