MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC GIA 100-3.8 SINGLE USE RELOADABLE; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number GIA10038S

Device Problem Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/23/2014

Event Type  Injury  

Event Description

Procedure type: lung resection.According to the reporter: the customer reports that there was a defective stapling on the parenchymatous bridge during a coelioscopy.There was blood loss of more than 500ccs and the patient was injured.Awaiting additional information.

Manufacturer Narrative

(b)(4).

• Brand Name: GIA 100-3.8 SINGLE USE RELOADABLE
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3889094
• MDR Text Key: 4538752
• Report Number: 2647580-2014-00430
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031860
• 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: 05/14/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: GIA10038S
• Device Lot Number: P3D0582X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other