FDA Adverse Event Injury Summary report: N

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

MDR report key: 9507765 · Received December 20, 2019

Report

Report Number: 3005075853-2019-24715
Event Type: Injury
Date Received: December 20, 2019
Report Date: November 29, 2019
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: LFL
PMA / PMN Number: K051036
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2019. MEDICAL DEVICE: 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.

Description of Event or Problem · 1

TITLE: LAPAROSCOPIC MYOMECTOMIES FOR LARGE FIBROIDS. AUTHOR : KAMRAN W.; THUMULURU K.M.; PAPATHEODOROU D.; BUTLER-MANUEL S.A.. CITATION: GYNECOL SURG (2009) 6 (SUPPL 1): S80; DOI 10.1007/S10397-009-0521-3. THIS RETROSPECTIVE STUDY AIMED TO ASSESS SAFETY AND EFFICACY OF PERFORMING LAPAROSCOPIC MYOMECTOMY USING HARMONIC ACE IRRESPECTIVE OF SIZE, NUMBER AND LOCATION OF UTERINE FIBROIDS. FROM MARCH 2005 TO MARCH 2009, A TOTAL OF 30 NON-PREGNANT WOMEN WITH SYMPTOMATIC FIBROIDS UNDERWENT LAPAROSCOPIC MYOMECTOMY REGARDLESS OF THE SIZE, NUMBER, OR LOCATION OF FIBROIDS WERE INCLUDED IN THE STUDY. MYOMECTOMIES WERE UNDERTAKEN USING HARMONIC ACE (ETHICON). COMPLAINTS INCLUDED MEAN BLOOD LOSS OF 146.7 ML (50¿1000 ML) (N=30). NONE OF THE PATIENTS RECEIVED BLOOD TRANSFUSION. IN CONCLUSION, LAPAROSCOPIC MYOMECTOMY IS A SAFE PROCEDURE IN EXPERIENCED HANDS FOR REMOVAL OF LARGE FIBROIDS..

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1294912	ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)	INSTRUMENT, ULTRASONIC SURGICAL	LFL	ETHICON ENDO-SURGERY, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention