• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number ILSX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure to Anastomose (1028); Pain (1994); Sepsis (2067); Peritonitis (2252); No Code Available (3191)
Event Date 08/26/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Date sent: 9/29/2020. Batch # unk. The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.

 
Event Description

It was reported that on (b)(6) 2019, patient underwent robotic assisted surgery for a colovaginal fistula repair which involved a stapled anastomosis. The patient returned five days later with severe pain, peritonitis, and sepsis and underwent an exploratory laparotomy, abdominal wash, and a hartman¿s procedure. The surgeon discovered a complete disruption of the staple line with misfired staples and absent staples and drains and a colostomy were placed. Following the surgery, the surgeon informed the patient that the ¿stapler had malfunctioned and misfired and was part of a recall and that the stapler was made by ethicon. ¿.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLAPAROSCOPE, 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 Key10599261
MDR Text Key208944265
Report Number3005075853-2020-04999
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 OTHER
Type of Report Initial
Report Date 09/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-