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 Failure to Anastomose (1028); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.Date of event: publication year of 2002.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 : results of laparoscopically assisted colon resection for carcinoma author : c.A.Anderson, f.R.Kennedy, m.Potter, h.L.Opie, s.Flowers, s.Lewis, m.Belmont, d.L.Fowler citation: surg endosc (2002) 16:607-610; doi: l 0.1007/s004640080079.This prospective study discussed about the results of first 100 patients treated with laparoscopically assisted colectomy for colorectal carcinoma.From october 1990 to march 1999, out of 100 patients (male=39, female=61; mean age=72.9 years, age range=28-98 ± 12.7 years), 93 patients underwent resection with curative intent.During the procedure, all the resections were performed in a similar fashion.Each patient had preoperative colonoscopy, and some patients underwent intraoperative colonoscopy to locate the lesion.Port placements varied depending on the type of resection performed.The colon was mobilized as in open surgery.This was accomplished with either dissecting scissors or ultrasonically activated shears (laparosonic coagulating shears, ethicon).Reported complications included anastomotic leak (n=2); postoperative bleeding (n=2); and anastomotic bleed (n=1).In conclusion, laparoscopically assisted colectomy for cancer can be performed safely.The recurrence rate after laparoscopically assisted resection appears to be at least as good as after open resection.

• 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: 9604336
• MDR Text Key: 188685351
• Report Number: 3005075853-2020-00461
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: LCSXX
• 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
• Patient Outcome(s): Required Intervention