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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM) STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM) STAPLER, SURGICAL Back to Search Results
Model Number EEA31
Device Problems Entrapment of Device (1212); Failure to Cut (2587)
Patient Problem No Code Available (3191)
Event Date 10/29/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter; during use a low anterior resection procedure for anastomosis, when the instrument was fired, the surgeon could not get the instrument out of the patient. The doctor assumes that the knife had not cut. There was an extension of surgery time by 1 hour, and tissue loss as the surgeon had to resect the first anastomosis, and create a new one. There was no additional blood loss, no change of procedure, and nothing fell into the patient cavity. No reinforcement material was in use at the time of the issue. The patient is reported to be okay without any report issue resulting from the extended surgical time. No further details regarding patient, product or procedure were provided by the reporter.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of one eea 28mm single-use stapler. The visual inspection of the staple guide noted the instrument was fully applied. A microscopic examination of the device displayed nicks on the knife blade. Inspection of the anvil cutting ring showed shallow traces of knife impression and the ring was received partially severed. Functionally, the device was applied over the appropriate test media producing acceptable results. The knife cut the test media cleanly and completely, despite the noted knife blade damage. Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction. The information booklet cautions the user to make certain the section of the tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut or the staple line may not properly form. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

 
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Brand NameEEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (31MM - 4.8MM)
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6153477
MDR Text Key61695187
Report Number2647580-2016-01051
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeNO
PMA/PMN NumberK111825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2021
Device MODEL NumberEEA31
Device Catalogue NumberEEA31
Device LOT NumberP6B0337KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/07/2016 Patient Sequence Number: 1
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