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

Model Number EEA31

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).User facility is listed in initial reporter.(b)(4).

Event Description

According the reporter, the pliers didn't staple on the incus of the device.A laparotomy had to be done for a manual anastomosis.

• 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
• MDR Report Key: 6271274
• MDR Text Key: 65532601
• Report Number: 2647580-2017-00079
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/29/2016

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: 09/30/2021
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P6J0038KX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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): Other; Required Intervention