MAUDE Adverse Event Report: SURGICAL STAPLER; STAPLER, SURGICAL

Device Problem Device Slipped (1584)

Patient Problems Aspiration/Inhalation (1725); Death (1802)

Event Date 11/02/2017

Event Type  Death  

Event Description

My husband had esophagectomy on (b)(6) 2017 due to cancer, was discharged on (b)(6) 2017, readmitted (b)(6) 2017.Secondary surgery on (b)(6) 2017 revealed one of the staples had come undone.Surgeon closed without repair as he was afraid he would damage the areas where staples were still in place.My husband died on (b)(6) 2017.Among the four causes of death noted on the death certificate was "aspiration".Hospital was (b)(6) central location in (b)(6).Fda safety report id# (b)(4).

• Brand Name: SURGICAL STAPLER
• Type of Device: STAPLER, SURGICAL
• MDR Report Key: 9284353
• MDR Text Key: 165372557
• Report Number: MW5090876
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 69 YR