MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE

Model Number EEA31

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

Patient Problems Pneumonia (2011); No Code Available (3191)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

Title: hartmann¿s procedure and laparoscopic reversal versus primary anastomosis and ileostomy closure for left colonic perforation source: langenbecks arch surg (2015) 400:609¿616, doi 10.1007/s00423-015-1319-6.Received: 16 march 2015 /accepted: 16 june 2015 /published online: 26 june 2015, # springer-verlag berlin heidelberg 2015.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between august 2010 and march 2014, comparing hartmann¿s procedure and laparoscopic reversal versus primary anastomosis and ileostomy closure for left colonic perforation, the circular stapler was used during the laparoscopic hartman reversal.Seventeen out of 24 patients went thru with the laparoscopic hartman reversal procedure.Major post-reversal complications were one anastomotic leakage and one aspiration pneumonia requiring mechanical ventilation.

• Brand Name: EEA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10086518
• MDR Text Key: 191970387
• Report Number: 2647580-2020-01635
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523005554
• UDI-Public: 10884523005554
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR