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

Model Number EEA31

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, when they retracted the stapler after the creation of the anastomosis in a restoration of continuity after the stoma, the stapler stayed in the rectum.They pushed the stapler and they were able to retrieve it.They noted that the anastomosis was okay.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection under the microscope displayed nicks on the knife blade and functional evaluation resulted in no abnormalities related to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Additionally, the investigation detected a secondary condition of nicks on the knife blade that has no relationship to the reported condition.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: 7633697
• MDR Text Key: 112165909
• Report Number: 2647580-2018-03117
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P7L1164KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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