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

Catalog Number LCSXX

Device Problem Device Handling Problem (3265)

Patient Problems Nerve Damage (1979); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Hypoesthesia (2352); Blood Loss (2597); No Code Available (3191)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Lot number is unknown.Therefore, the 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(b)(4).

Event Description

Title: early experience of laparoscopically assisted radical vaginal.Hysterectomy (coelio-schauta) versus abdominal radical.Hysterectomy for early stage cervical cancer.Author : evangelos papacharalabous & anil tailor & thumuluru madhuri & theo giannopoulos & simon butler-manuel.Citation: gynecol surg (2009); 6:113¿117.Doi: 10.1007/s10397-008-0424-8.The objective of this study was to compare outcomes of laparoscopically assisted radical vaginal hysterectomy (larvh) vs.Abdominal radical hysterectomy (rh) for early-stage cervical cancer.This retrospective review involves all larvh for cervical cancer between january 2003 and june 2006 after introduction of larvh as a new procedure.During this period, 14 female patients (mean age: 38.6 years; age range: 25-81 years) underwent larvh.The operation results were compared with 12 female patients (mean age: 43.5 years; age range: 27-76 years) who underwent rh during the same period of time for cervical cancer.Pelvic lymph node dissection was done systematically using standardized technique.Ultracision harmonic scalpel (ethicon) was used throughout the laparoscopic cases that facilitated pelvic lymphadenectom.Ultracision harmonic scalpel (ethicon) was the primary instrument in all larvhs.Reported complications in the larvh group included intraoperative blood loss (mean: 725ml; range: 100-2000) (n-?), bladder perforation/cystotomies (n-2) which was repaired transvaginally, ureteric injury (n-1) and obturator nerve injury (n-1) in which all these injuries were repaired laparoscopically, unilateral neurapraxia of the obturator nerve (n-1), short-term urinary retention (n-1) in which the patient had to be discharged from the hospital with urinary catheter in situ for 10 days, unilateral thigh muscular atrophy following intraoperative injury to the obturator nerve (n-1), thigh paraesthesia and numbness (n-2), presumably due to inadvertent injury of lateral branches of the genitofemoral nerve, during lymphadenectomy, recurrent urinary tract infections (n-1) and adhesion (n-1) in which the patient underwent laparoscopic adhesiolysis.In conclusion, both larvh and rh appeared equally efficacious in the treatment of early-stage cervical cancer with no recurrences in either group, in contrast to other published data.A copy of this literature article is attached to this medwatch report.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9375935
• MDR Text Key: 168580940
• Report Number: 3005075853-2019-23753
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• 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
• Patient Outcome(s): Required Intervention