MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HDH05

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

Patient Problems Sepsis (2067); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Date 01/01/2003

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/16/2019.Date of event: publication year of 2003.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: laparoscopic extraperitoneal adenomectomy (millin): pilot study on feasibility authors: r.Van velthoven, a.Peltier, m.P.Laguna, and th.Piechaud citation: european urology 45 (2004) 103¿109.The objective of this pilot study is to describe the surgical technique and to assess the feasibility of laparoscopic extraperitoneal adenomectomy.Patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia were offered an alternative to an open millin operation between february 2001 to january 2003.Eighteen male patients with mean age of 67.83 were included and all underwent laparoscopic extraperitoneal adenomectomy.The operation was performed with primary introduction of 5mm and 10 mm ports for the laparoscope.The fat covering the prostatic capsule is dissected and two cross sutures (vicryl rapid® 1/0) are placed each on the lateral surface of the prostate.With the help of harmonic hook scalpel, the surgical capsular plane is developed distally in the direction of the apex, laterally to the posterior plane and cranially to the bladder neck.Trigonization is done by means of two to four stitches placed from the posterior bladder neck to the internal posterior aspect of the prostate fossa (vicryl rapid® 2/0).The anterior prostate capsule is closed by two running sutures (vicryl rapid®1 1/0 with a triangular needle).One patient developed sepsis due to persistent obstruction.The patient did not recuperate spontaneous micturition and a reoperation (turp) was performed three months later.One patient had minimal bleeding and was treated with single catheterization.Two patients required delayed catheterization for hematuria (single catheterization in one case and 2 days catheterization in the other case).One patient had low flow one month after the operation and a minimal stricture of the bulbar urethra was diagnosed a treated with a single dilatation.In conclusion, the authors reported that laparoscopic extraperitoneal adenomectomy (millin¿s procedure) is feasible with a reasonable complication rate.Although comparison with open adenomectomy is not yet available, this technique might have potential advantages in terms of blood loss and postoperative catheter time.

• Brand Name: HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP
• 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: 9477471
• MDR Text Key: 188515595
• Report Number: 3005075853-2019-24408
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002109
• UDI-Public: 10705036002109
• Combination Product (y/n): N
• PMA/PMN Number: K990362
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HDH05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention