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

Model Number EEAXL28

Device Problems Difficult to Remove (1528); Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).

Event Description

According to the reporter: the stapler fired but it did not cut.The tissue to be stapled was free from any metal clips or similar structures.The instrument handle was fully squeezed.The surgeon had problems removing the stapler.He managed to remove it from the tissue and oversew it.There was no patient injury or ill-effects.

• Brand Name: EEA XL 28MM 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6135880
• MDR Text Key: 61140872
• Report Number: 2647580-2016-01018
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• 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: EEAXL28
• Device Catalogue Number: EEAXL28
• Device Lot Number: P6B0126KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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): Required Intervention