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

Model Number EEA31

Device Problems Air Leak (1008); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Failure to Anastomose (1028); Tissue Damage (2104)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Procedure type: laparoscopic hand assisted sigmoid resection.According to the reporter: the stapler did not completely cut the tissue which made it difficult to remove after firing.There was an intra-operative air leak.The surgeon had to resect more tissue and redo the anastomosis.There was unanticipated tissue loss and the case was extended by more than 30 minutes.There was no bleeding reported in excess of 500cc.The surgeon used an eea28 to complete the case.Patient status: stable.

• Brand Name: EEA 31MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• 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: 5017056
• MDR Text Key: 23520783
• Report Number: 2647580-2015-00589
• 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 faci
• Reporter Occupation: Health Professional
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P5A0191KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability