MAUDE Adverse Event Report: COVIDEN (DISTRIBUTED BY CARDINAL HEALTH 1-800-964-5227) 1-800-962-9888 ENDO CATCH II 15 MM; SINGLE USE SPECIMEN RETRIVAL POUCH

Model Number 173049

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 08/06/2015

Event Type  Injury  

Event Description

Patient was having robotic surgery for a lung resection on (b)(6) 2015.During the use of the endo catch, part of the bottom of the plastic bag separated away.Two pieces of the bag were retrieved.The bag is stretched out and it is impossible to fit the pieces back together to say with certainty if all pieces were retrieved.The surgeon did a thorough check and feels confident that all pieces were retrieved.This bag is non-x-ray detectable.It is a disposable piece of equipment-1x use.

• Brand Name: ENDO CATCH II 15 MM
• Type of Device: SINGLE USE SPECIMEN RETRIVAL POUCH
• Manufacturer (Section D): COVIDEN (DISTRIBUTED BY CARDINAL HEALTH 1-800-964-5227) 1-800-962-9888; mansfield MA
• MDR Report Key: 5011267
• MDR Text Key: 23434249
• Report Number: MW5055477
• Device Sequence Number: 1
• Product Code: GCI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173049
• Device Lot Number: J5B0519X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95