ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
Report
- Report Number
- 3005075853-2019-23781
- Event Type
- Injury
- Date Received
- November 26, 2019
- Date of Event
- January 1, 2013
- Report Date
- October 30, 2019
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K051036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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. DATE SENT: 11/25/2019. DATE OF EVENT: PUBLICATION YEAR OF 2013. 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. (B)(4).
TITLE : TOTAL LAPAROSCOPIC WERTHEIM¿S RADICAL HYSTERECTOMY VERSUS WERTHEIM¿S RADICAL ABDOMINAL HYSTERECTOMY IN THE MANAGEMENT OF STAGE I CERVICAL CANCER IN SINGAPORE: A PILOT STUDY. AUTHOR : YONG KUEI LIM1, MBBS, MRCOG, YIN NIN CHIA1, MBBS, MRCOG, KWAI LAM YAM1, MBBS, FRCOG. TITLE: TOTAL LAPAROSCOPIC WERTHEIM¿S RADICAL HYSTERECTOMY VERSUS WERTHEIM¿S RADICAL ABDOMINAL HYSTERECTOMY IN THE MANAGEMENT OF STAGE I CERVICAL CANCER IN SINGAPORE: A PILOT STUDY AUTHORS: YONG KUEI LIM, MBBS, MRCOG; YIN NIN CHIA, MBBS, MRCOG; KWAI LAM YAM, MBBS, FRCOG CITATION: SINGAPORE MED J 2013; 54(12): 683-688; DOI: 10.11622/SMEDJ.2013242. THE AIM OF THIS PROSPECTIVE STUDY WAS TO DESCRIBE THE EARLY EXPERIENCE OF TOTAL LAPAROSCOPIC WERTHEIM¿S RADICAL HYSTERECTOMY (TLRH) IN THE MANAGEMENT OF EARLY CERVICAL CANCER IN SINGAPORE. FROM NOVEMBER 2009 TO FEBRUARY 2011, A TOTAL OF 18 PATIENTS (MEAN AGE = 48 YEARS, AGE RANGE = 30-65 YEARS; MEAN BMI 22.9 KG/M^2, BMI RANGE = 16.0 ¿ 33.7 KG/M^2) UNDERWENT TO TLRH GROUP AND 30 PATIENTS (MEAN AGE = 47 YEARS, AGE RANGE = 33-67 YEARS; MEAN BMI 22.4 KG/M^2, BMI RANGE = 17.9 ¿ 33.9 KG/M^2) UNDERWENT WERTHEIM¿S RADICAL ABDOMINAL HYSTERECTOMY (RAH). TLRH BEGAN WITH THE DEVELOPMENT OF THE PELVIC SPACES. THE EXTERNAL ILIAC, INTERNAL ILIAC, OBTURATOR AND COMMON ILIAC LYMPH NODES WERE SYSTEMATICALLY REMOVED EN BLOC THROUGH THE SUPRAPUBIC PORT USING THE HARMONIC ACE CURVED SHEARS (ETHICON). THE URETERS WERE DISSECTED OFF THE MEDIAL PERITONEAL ATTACHMENTS BY BLUNT DISSECTION AND MOBILISED DOWN TO THE UTERINE ARTERIES. THE UTERINE ARTERY AND VEIN WERE TRANSECTED AT THE POINT OF ORIGIN FROM THE INTERNAL ILIAC VESSELS USING THE HARMONIC ACE CURVED SHEARS. REPORTED COMPLICATION IN TLRH GROUP INCLUDED MEDIAN BLOOD LOSS OF 300 ML (RANGE = 100 ¿ 1000 ML) (N=?); HAEMORRHAGE FROM THE PARAMETRIAL VESSELS (N=1) WHICH REQUIRED CONVERSION TO LAPAROTOMY. IN CONCLUSION, THE RESULTS OF THE STUDY SUGGEST THAT WITH APPROPRIATE PATIENT SELECTION AND INCREASED EXPERIENCE, TLRH CAN BE A SAFE AND EFFECTIVE PROCEDURE FOR THE MANAGEMENT OF EARLY CERVICAL CANCER IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1170985 | ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |