MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA PLATE, BASE, SHELLAC

Model Number TRIEEA28MT

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic procedure, on anastomosis of the rectum, it was difficult to remove the stapler form the cavity. The surgeon had to remove the instrument by inserting his finger rectally and assist digitally to remove the instrument. There was no patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic rectal resection with ileostomy procedure, on anastomosis of the rectum, it was difficult to remove the stapler from the cavity. The surgeon had to remove the instrument by inserting his finger rectally and assist digitally to remove the instrument. There was no patient injury.

• Brand Name: EEA
• Type of Device: PLATE, BASE, SHELLAC
• 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: 7907992
• MDR Text Key: 121704677
• Report Number: 2647580-2018-04697
• Device Sequence Number: 1
• Product Code: EEA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TRIEEA28MT
• Device Catalogue Number: TRIEEA28MT
• Device Lot Number: P8A0976X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial