MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN; STAPLE, IMPLANTABLE

Model Number UNKNOWN EGIA SU

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient underwent a laparoscopic sleeve gastrectomy.The patient began experiencing chest pain and shortness of breathe shortly after the procedure.The patient remained in the hospital for a few days.The patient returned to the emergency room with continuous shortness of breathe and chest pains.It was determined the patient had pleural effusion into the left chest from a leak and underwent additional medical procedure.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10058405
• MDR Text Key: 191101802
• Report Number: 1219930-2020-02037
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EGIA SU
• Device Catalogue Number: UNKNOWN EGIA SU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR