MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

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

Patient Problems Nerve Damage (1979); Weakness (2145)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/26/2019.Date of event: publication year of 2017.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: case report on near total transection of the obturator nerve and primary repair during laparoscopic radical hysterectomy for cervical cancer.Author/s: lim t.Y.K.Citation: bjog: an international journal of obstetrics and gynaecology.124 (supplement 1) (pp 97), 2017 / http://dx.Doi.Org/10.1111/1471-0528.6_14572.The purpose of this case report is to discuss incidence of near total transection of the obturator nerve during laparoscopic radical hysterectomy.This is concerning a (b)(6)-year-old woman who have a 1-cm cervical tumour.The patient had a stage ib1 squamous cell carcimona of the cervix and underwent total laparoscopic wertheim's radical hysterectomy bilateral salpingo-oophorectomy, bilateral pelvic lymphadenectomy in feb 2015.During the pelvic lymphadenectomy, the left obturator nerve was inadvertently damaged and partially transected by the harmonic scalpel (ethicon).The nerve was reconstituted by interrupted 5-o vicryl suture to the epineural layer of the nerve.Postoperatively, the patient experienced weakness of the adductor muscles (3/5) but negligible sensory loss.Four months after intensive physiotherapy, the motor deficit was markedly reduced and her gait was normal.There was no sensory loss.Obturator nerve injury is a rare complication with a significant clinical impact if unrecognised.In uncomplicated cases, laparoscopic route of repair is feasible and safe and an immediate repair of the nerve is preferable.

• Brand Name: HARMONIC ACE 5MM SHEAR
• 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: 9520133
• MDR Text Key: 189083206
• Report Number: 3005075853-2019-24751
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/26/2019
• 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