MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA ORVIL; STAPLE, IMPLANTABLE

Model Number EEAORVIL21

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/16/2018

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 the introduction of the catheter into the stomach in a laparoscopic rouxen gastric bypass, the tube dislodged from the device prematurely and it fell into the patient¿s cavity.They were able to retrieve the distal cap of the device from the patient¿s cavity by removing the device orally.There was no patient injury.

• Brand Name: EEA ORVIL
• 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: 7537559
• MDR Text Key: 109039338
• Report Number: 1219930-2018-02837
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521042841
• UDI-Public: 10884521042841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEAORVIL21
• Device Catalogue Number: EEAORVIL21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• 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 Age: 62 YR