MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number 030459

Device Problems Detachment Of Device Component (1104); Failure to Form Staple (2579)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 06/07/2018

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 laparoscopic lower left lobectomy, while on parenchyma cutting, there was poor staple formation, staple line incomplete at the center, that caused bleeding.The staple line was over sewn.A component of the device that fell into the cavity was also reported.The surgical time extended 30 minutes.Replaced by a new device to complete the case.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• 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: 7630749
• MDR Text Key: 112072718
• Report Number: 1219930-2018-03352
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002904
• UDI-Public: 10884523002904
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 030459
• Device Catalogue Number: 030459
• Device Lot Number: N7E0468KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 05/12/2017
• 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: 29 YR