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

Model Number 030458

Device Problems Failure to Advance (2524); Misfire (2532); Failure to Form Staple (2579)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic sleeve gastrectomy, the devices did not receive formation.It was unformed at the distal part as 1 cm and the knife could not be advanced.The smooth formation did not occur on the region where the closure happened.The operation was changed to open procedure and the formation problem was seen by the physician¿s observation.The unformed and open areas were repaired with suture after passing through open surgery.The test was done and there was no problem.All the resected lines were sutured, therefore the nutritional status of the patient was unclear, and for this reason the patient will be staying in the hospital for 5 more days.The surgical time was extended to 1 hour and 30 minutes because of the product issue.There was a 1 unit of blood given to the patient due to blood loss.

Manufacturer Narrative

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

• 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: 7762925
• MDR Text Key: 116437631
• Report Number: 1219930-2018-04340
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002898
• UDI-Public: 10884523002898
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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 Expiration Date: 03/31/2023
• Device Model Number: 030458
• Device Catalogue Number: 030458
• Device Lot Number: N8C1237KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/02/2018
• Date Device Manufactured: 03/29/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 155