Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, INC. ENDOPOUCH; LAPAROSCOPE, GENERAL
  • 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, INC. ENDOPOUCH; LAPAROSCOPE, GENERAL Back to Search Results
Catalog Number POUCH
Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/13/2016
Event Type  malfunction  
Event Description
The epigastric port was enlarged slightly to accommodate the endopouch.Upon pulling the bag with the gallbladder through, the bottom part of the bag fragmented and came out.The gallbladder was then delivered.It was noted that there was a tiny piece of the plastic endopouch, which had broken off of the main bag.It was thought initially that it was visualized in the epigastric trocar site.Thorough exploration of the site and the intraperitoneal cavity for a small 2-3mm piece of the bag was uneventful.We were unable to find the piece.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOPOUCH
Type of Device
LAPAROSCOPE, GENERAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242
MDR Report Key6120481
MDR Text Key60788622
Report Number6120481
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2021
Device Catalogue NumberPOUCH
Device Lot NumberN4LY9T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age60 YR
Patient Weight73
-
-