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

MAUDE Adverse Event Report: ETHICON POWER CIRCULAR STAPLER (EEA)

  • 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 POWER CIRCULAR STAPLER (EEA) Back to Search Results
Device Problems Off-Label Use (1494); Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931)
Event Date 05/24/2019
Event Type  Injury  
Event Description

On (b)(6) 2019 pt underwent exploratory laparotomy with bowel resection. Due to the pt's anatomy dr used from up above versus using it transanally. On (b)(6) the pt was brought back to the operating room for a abdominal washout, with loop ileostomy.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWER CIRCULAR STAPLER (EEA)
Type of DeviceSTAPLER
Manufacturer (Section D)
ETHICON
4545 creek road
cincinnati OH 45242
MDR Report Key8811608
MDR Text Key151771140
Report Number8811608
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 RISK MANAGER
Type of Report Initial
Report Date 06/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2019
Distributor Facility Aware Date05/30/2019
Event Location Hospital
Date Report TO Manufacturer06/10/2019
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/19/2019 Patient Sequence Number: 1
-
-