MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD; MESH, SURGICAL, DEPLOYER

Model Number EGIATRS60AMT

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device manufacture date: since the lot number was not provided, this information cannot be determined.Surgical intervention required.

Event Description

According to the reporter, the patient presented with a leak 12 days post op after a sleeve gastrectomy procedure, which was diagnosed through an esophagogastroduodenoscopy.The inter-operative leak test was negative.They put a drain in and a feeding tube.The patient is at home and is doing well.

• Type of Device: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6283598
• MDR Text Key: 65964512
• Report Number: 1219930-2017-00113
• Device Sequence Number: 1
• Product Code: ORQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133938
• 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: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MANUAL STAPLER HANDLE
• Patient Outcome(s): Other; Required Intervention