MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEA31

Device Problem Misfire (2532)

Patient Problem Tissue Damage (2104)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

User facility listed in initial reporter.(b)(4).Patient information not provided.Udi not provided.Re-processing information not provided.

Event Description

According to the reporter, while the surgeon was doing lap anterior resection on today, he used stapler for anastomosis but after the application the donut was incomplete and only half of the anastomotic lip got stapled.Surgeon and scrub sister confirms that staple pins were not properly pushed by the stapler results in incomplete donut.Suture was used to correct the staple line.The patient is stable.There was some partial tissue damage.The surgical time was delayed over 30 minutes due to the problem.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one eea 31mm single-use stapler.The visual inspection of the staple guide noted the instrument was fully applied.A microscope 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 reloaded with a full complement of staples and applied over the appropriate test media producing acceptable results.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 31MM SINGLE-USE STAPLER
• 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: 6133170
• MDR Text Key: 61057469
• Report Number: 2647580-2016-01014
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P4M0355KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 27