MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO EEA 28MM SINGLE-USE STAPLER; DISPOSABLE SURGICAL STAPLER

Catalog Number EEA28

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Procedure type: gastrectomy: according to the reporter: the eea punctured and put a hole in the anastomosis.It was stated that the surgeon squeezed the handle multiple times.As a result of the punctured bowel, the surgeon had to over-sew the anastomotic site using suture.It was also reported that there was difficulty in removing the device from the tissue and that there was a lack of audible feedback after turning the black open and close knob.There was unanticipated tissue damage.There was unanticipated tissue loss.There was no bleeding reported in excess of 500cc.The case was extended by 45 mins.

Manufacturer Narrative

(b)(4).

• Brand Name: EEA 28MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3889146
• MDR Text Key: 16186856
• Report Number: 2647580-2014-00438
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: EEA28
• Device Lot Number: P3H0305X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other