MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM); STAPLER, SURGICAL

Model Number EEA28

Device Problems Difficult to Remove (1528); Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Tissue Damage (2104)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No further details regarding patient, product or procedure were provided by the reporter.

Event Description

According to the reporter, during a laparoscopic sigmoidectomy procedure, after firing the device, the wing nut was rotated twice but there was no click sound or feeling.The surgeon tried to remove the device, but there was resistance.The device was eventually removed by force.Surgeon felt that he tore the tissue at the time.They checked the anvil and confirmed that some staples were stuck into the knife groove.The udi number is not available.The event occurred in use for patient.The surgical time was not extended.Additional tissue resection is not required.There was tissue damage.The incision site was not extended.Nothing fell into the patient's cavity.The device was removed from the tissue by force and tissue damage was caused however according to the account treatment was not needed for the damage.No bleeding occurred.The patient gender is not available.The patient age is not available.The patient weight is not available.The device was not reprocessed/re-sterilized prior to use.Additional information from the account provided that the tissue was slightly thick.Reinforcement material was not used in conjunction with the device at the time.The patient is reported to have had a slight fever 2 days after the surgery.No leakage was observed.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one stapler opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The visual inspection of the staple guide noted the instrument was fully applied.The anvil of the instrument was observed to be tilted and attached to the instrument.A microscope examination of the device displayed nicks on the knife blade.In addition, a deep knife impression and cross cutting staple line marks were observed along the cutline impression in the cutting ring and mylar cover.Functionally, the device was reloaded with a full complement of staples and applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely, despite the noted knife blade damage and the staple line was properly formed.The device did not produce an audible click after two full turns of the knob after firing.The device did produce tactile feedback after two full turns of the knob after firing.The secondary audible feedback condition has been brought to the attention of the appropriate personnel.A process enhancement has been initiated to prevent this condition from recurring.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA¿ AUTO SUTURE¿ CIRCULAR STAPLER WITH DST SERIES¿ TECHNOLOGY (28MM - 4.8MM)
• Type of Device: STAPLER, 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6070841
• MDR Text Key: 58916230
• Report Number: 2647580-2016-00905
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P6B0614KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other