MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN GIA PREMIUM; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number 030715

Device Problem Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during open gastrectomy, when firing stomach, poor staple formation was observed.The staple line had to be oversewn to complete the case.Surgical time was extended by 30 minutes or more due to the reported event.

• Brand Name: GIA PREMIUM
• Type of Device: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10077073
• MDR Text Key: 191663714
• Report Number: 1219930-2020-02086
• Device Sequence Number: 1
• Product Code: FHM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 030715
• Device Catalogue Number: 030715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/20/2020
• 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