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

Catalog Number LCSXX

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

Patient Problems Wound Dehiscence (1154); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.Date of event: publication year of 2004.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: ultracision harmonic scalpel and multifunctional tem400 instrument complement in transanal endoscopic microsurgery author : i.D.Ayodeji, w.C.J.Hop, g.W.M.Tetteroo, h.J.Bonjer, e.J.R.De graaf.Citation: surg endosc (2004) 18: 1730¿1737; doi: 10.1007/s00464-003-9331-2.This prospective study discussed about the ultracision harmonic scalpel (uc) and multifunctional tem400 instrument (t400) complement in transanal endoscopic microsurgery (tem).Between 1996 and 2002, 196 tumors were excised in 184 patients.The t400 was used for 162 tumors t400 (female=77, male=85; mean age=70 years, age range=40-92 years), and the uc for 34 tumors (female=16, male=18; mean age=68 years, age range=35-87 years).Ultracision harmonic scalpel (ethicon) was used during the procedure.Reported complications included rebleeding (n=1); and anastomotic dehiscence (n=1).In conclusion, the uc substantially reduced operative time compared with the t400, but frequently required the t400 for procedure completion.The t400 is always singly sufficient.

• 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: 9604308
• MDR Text Key: 188688499
• Report Number: 3005075853-2020-00460
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1