MAUDE Adverse Event Report: CONMED; TROCAR PROCEDURE KIT

Model Number CD7530G

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/16/2014

Event Type  malfunction  

Event Description

During a laparoscopic appendectomy the conmed core dynamics trocar procedure kit was used with the reusable trocars with this kit.The inner cone seal was pushed through the cannula when the covidien stapler was inserted (endo gia stapler).The seal was retrieved but we wanted to report it as this could easily become a retain object.Lot number of the actual product used was not obtained; however, another unused product on hand had the lot number of 1309231.

• Type of Device: TROCAR PROCEDURE KIT
• Manufacturer (Section D): CONMED
• MDR Report Key: 3701819
• MDR Text Key: 18362126
• Report Number: MW5035193
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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 Model Number: CD7530G
• Device Lot Number: 1309231
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR