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

Catalog Number EGIAUSTND

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Tissue Damage (2104)

Event Date 08/26/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: bullectomy.According to the reporter: during use a doctor heard strange sounds from the handle and recognized some difficulty in squeezing it.Then the firing was suspended halfway with the blade advanced to the middle.Additional tissue resection was required to resolve the issue.The case was completed with no problem by using another stapling device.Operating time was extended less than 30 minutes.It is unknown whether reinforcement material was used.The last known patient status was reported as good.

• Brand Name: EGIA ULTRA UNIVERSAL STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; ponce
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; ponce
• Manufacturer Contact: sharon murphy ; covidien; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4112846
• MDR Text Key: 19373620
• Report Number: 2647580-2014-00755
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P4C0194X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Treatment: EGIA60AVM, EGIA 60 ARTICULATING VAS/MED SULU,
• Patient Outcome(s): Disability