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. CONTOUR; STAPLER, SURGICAL
  • 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. CONTOUR; STAPLER, SURGICAL Back to Search Results
Catalog Number CS40B
Device Problem Failure to Form Staple (2579)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  malfunction  
Event Description
The general surgeon used the contour curved cutter to divide the bowel during a low anterior resection.When the specimen came out he noted that the stapled end was not closed on the specimen, when he looked at the other end the staples had not closed either.The stapler cut but the staples did not close properly.The stapler was taken to materials management and sequestered awaiting pick-up by the ethicon (j&j) rep to retrieve manufacturer response for contour curved cutter stapler, contour curved cutter stapler (per site reporter: we have the stapler and the manufacturer rep is aware that it is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR
Type of Device
STAPLER, SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242
MDR Report Key5972711
MDR Text Key55441919
Report Number5972711
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2018
Device Catalogue NumberCS40B
Device Lot NumberK4082K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/16/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/23/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; NOT ANY DEVICES THAT CONTRIBUTED TO THE STAPLER FA
Patient Age70 YR
-
-