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

MAUDE Adverse Event Report: COVIDIEN CURVED STAPLER 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
 

COVIDIEN CURVED STAPLER STAPLER, SURGICAL Back to Search Results
Catalog Number 3400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930); Pain (1994)
Event Date 10/18/2019
Event Type  Injury  
Event Description

Pt was admitted for surgery (b)(6) 2019 with dx rectal ca. He was readmitted (b)(6) 2019 due to rectal pain. Op findings from (b)(6) 2019 include "rectal examination revealed findings consistent with an anastomotic dehiscence, with contaminant within the presacral space, presacral pelvic abscess" which qualifies this case as a surgical site infection (organ/space of the gi tract). Fda safety report id#s (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCURVED STAPLER
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN
MDR Report Key9865162
MDR Text Key184665003
Report NumberMW5093869
Device Sequence Number3
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/18/2020
4 DeviceS WERE Involved in the Event: 1   2   3   4  
1 Patient Was Involved in the Event
Date FDA Received03/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3400
Device LOT Number3400
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/20/2020 Patient Sequence Number: 1
-
-