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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH STEALTH CIR STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. ENDOPATH STEALTH CIR STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number ILSX
Device Problem Leak/Splash (1354)
Patient Problems Failure to Anastomose (1028); Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Peritonitis (2252); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). As a lot/batch was not provided, a device history could not be performed. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does the author believe that any post operative leaks experienced during the study related to an alleged deficiency of an ethicon device?.

 
Event Description

It was reported via a journal article: "title: regenerated oxidized cellulose reinforcement of low rectal anastomosis: do we still need diversion? authors: khaled m. Madbouly, m. D. , ph. D. , ahmed hussein, m. D. , ph. D. , waleed omar, m. D. , ph. D. , mohamed farid, m. D. , ph. D. Citation: dis colon rectum 2010; 53: 889¿895. Doi: 10. 1007/dcr. 0b013e3181d3206e. The aim of this study was to evaluate the effect of oxidized regenerated cellulose (oc) reinforcement on the outcome of ow rectal anastomosis. The study population comprised 108 adults with mid and low rectal cancer who presented between may 2003 and december 2008. Patients were selected if they were amenable to low anterior resection and had colorectal or coloanal anastomosis. A total of 71 were included in the study and randomized. Straight low colorectal anastomosis using a 29-mm circular stapler (ethicon endo-surgery) was performed between the descending colon and the rectal stump without proximal diversion. Patients were prospectively randomized into 2 groups. In the first group, the anastomoses were reinforced using oc (ocr: n=33; 19 men, 14 women mean age 55 years) (surgicel nu-knit, absorbable hemostat, ethicon endo-surgery). In the second group, no reinforcements were performed (nr: n=38; 20 men, 18 women; mean age 57 years). In the ocr group, 2 rings of oc were cut with the exact circumference of both the stapler top ring and the anvil bottom ring. One ring was fixed to the stapler and the other, to the bottom ring of the anvil using steri-strips. Study outcomes include: bleeding from the staple line (nr, n=4), incomplete doughnut ring (ocr, n=1; underwent proximal diversion), air leak during anastomotic testing at surgery (ocr, n=1; nr, n=1; both underwent proximal diversion), pelvic hematoma (nr, n=3), anastomotic leaks (ocr, n=2; nr, n=6), wound infection from anastomotic leak (ocr, n=2; nr, n=3 [all were pelvic abscesses ¿ managed by ct-guided drainage and intravenous antibiotics]), generalized peritonitis from anastomotic leak (nr, n=3 [underwent reexploration ¿ 2 were proximaly diverted, 1 received peritoneal lavage and had an end colostomy after closure of the rectal stump]), prolonged ileus (ocr, n=4; nr, n=3), abdominal wound dehiscence (ocr, n=1). The data demonstrate that oc reinforcement of low rectal anastomosis significantly decreases the risk of postoperative leak in low rectal anastomosis and probably limits the need for proximal diversion. Oc also decreases the need for surgical interference in the case of a leak. ".

 
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Brand NameENDOPATH STEALTH CIR STAPLER
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key7011764
MDR Text Key91413594
Report Number3005075853-2017-05975
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberILSX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/08/2017 Patient Sequence Number: 1
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