MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

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

Patient Problems Failure to Anastomose (1028); Abscess (1690); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported via journal article: title: clinical assessment of short-term outcome of sphincter-sparing surgery in patients with low rectal carcinoma.Authors: emad hokkama; mohamed faisal; mohamed shams; ahmed gomaa; hamada fathey.Citation: egyptian j surgery 38:250¿256; doi: 10.4103/ejs.Ejs_185_18.The aim of this prospective study is to evaluate early outcome of sphincter-sparing surgery in patients with low rectal cancer.Between february 2014 and january 2017, 153 patients with proven endoscopic biopsy for primary low rectal carcinoma were enrolled in the study.During the procedure, the sigmoid colon was divided proximally, and the rectum was resected with distal safety margin of at least 1.5 cm with the help of ethicon contour curved cutter stapler (ethicon) to close the distal stump.Whenever possible, the anastomosis was established through the abdomen using the ethicon circular staplers (ecsa-29 and ecsa-33 stapler; ethicon) according to the diameter of rectum and sex of the patient.Reported complications included anastomotic leak (n=6) in which half of them were managed by repairing and saving the anastomosis whereas the other half were managed by definitive colostomy; pelvic abscess (n=7) which was treated by ultrasound-guided drainage; anastomotic stenosis (n=18) treated by manual dilation; grade ii incontinence (n=16); grade iii incontinence (n=8); grade iv incontinence (n=2).In conclusion, sphincter-sparing surgery for low rectal carcinoma is a good option to avoid permanent stoma with its associated morbidity and social and psychic effects.It has accepted oncological and functional outcomes.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9967244
• MDR Text Key: 192047128
• Report Number: 3005075853-2020-02189
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention