MAUDE Adverse Event Report: COVIDIEN COVIDIEN ENDO CATCH GOLD

Lot Number J7M2009MX

Device Problem Device Slipped (1584)

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

Event Date 05/02/2018

Event Type  Injury  

Event Description

Laparoscopic appendectomy case near closure.Endo catch bag device inside pt with appendix inside bag and surgeon pulled on "invalid" to remove it from umbilical incision site.Bag seam not sealed correctly and bag came out of incision site with appendix remaining in abdomen.New balloon trocar needed to be placed in umbilicus due to extra adipose tissue.Insufflation and camera needed to be started back up and surgeon needed to use new endo catch bag to retrieve appendix out of abdomen.This lengthened surgery time and pt under anesthesia for longer than necessary due to failure of device.

• Brand Name: COVIDIEN ENDO CATCH GOLD
• Type of Device: ENDO CATCH GOLD
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7494126
• MDR Text Key: 107739907
• Report Number: MW5077057
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Lot Number: J7M2009MX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR