MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIA ULTRA UNIVERSAL STAPLER; DISPOSABLE SURGICAL STAPLER

Model Number EGIAUSTND

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Sticking (1597); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  Injury  

Event Description

According to the reporter: when stapling across bowel the stapler clamped down onto the tissue and locked up.The surgeon was unable to release the stapler and had to open another stapler and staple around the locked device in order to remove it from the patient with the bowel still stuck in the device.The additional step would not have been necessary had the stapler fired properly.No patient harm was done just the unnecessary extra stapling.

Manufacturer Narrative

(b)(4).

• Brand Name: EGIA ULTRA UNIVERSAL STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLER
• 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: 4308426
• MDR Text Key: 5135286
• Report Number: 2647580-2014-01038
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P4F0133X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Disability