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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC; STAPLER, SURGICAL
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MEDTRONIC; STAPLER, SURGICAL Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Dyspnea (1816); Fever (1858); Hypoxia (1918); Tachycardia (2095); Complaint, Ill-Defined (2331); No Code Available (3191)
Event Date 01/08/2019
Event Type  Injury  
Event Description
Patient arrived to the or for a planned colostomy reversal.2 days later: wbc elevated - ua (+) uti - abx.Started.2 days later: new fever, tachycardic, hypoxic, dyspneic, llq pain, loose stools, n/v.Ct of her abd/pelvis demonstrated small fluid in abdomen; appendix is dilated.1 day later: to or for exploratory lap - abd.Washout, end colostomy, oversewing of rectal stump.Anastomatic leak - enteric material in pelvis - purulent material in the subcutaneous tissue of the incision.Patient cont'd to not feel well and approximately 1 week later, she went to ir for a ct-guided drainage of pelvic abscess with drain placement.Approximately 1 week later: pt.Discharged to snf.
 
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Type of Device
STAPLER, SURGICAL
Manufacturer (Section D)
MEDTRONIC
15 hampshire street
mansfield MA 02048
MDR Report Key8707297
MDR Text Key148328843
Report Number8707297
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/14/2019
Event Location Hospital
Date Report to Manufacturer06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age24455 DA
Patient Weight95
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