MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA PREMIUM; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number 030735L

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

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 an open right hemicolectomy procedure, while dividing the colon, the surgeon could not fire the device.The black pusher thumb could not be moved at all.After inspection of the reload, they noticed that there were no staples in rows.They used a new reload with the same handle, and everything gone well.There was no patient injury.

• Brand Name: GIA PREMIUM
• Type of Device: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• 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: 8471687
• MDR Text Key: 140588792
• Report Number: 2647580-2019-01759
• Device Sequence Number: 1
• Product Code: FHM
• UDI-Device Identifier: 10884521031630
• UDI-Public: 10884521031630
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K801590
• 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
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 030735L
• Device Catalogue Number: 030735L
• Device Lot Number: P8G1401X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/01/2019
• Date Device Manufactured: 07/21/2018
• 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