MAUDE Adverse Event Report: CONMED CORPORATION ENTREE II DISPOSABLE TROCAR PROCEDURE KIT; TROCAR KIT

Catalog Number CD7100G

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The device has been received at conmed corporation on (b)(6) 2016.The evaluation has not yet commenced on the device.On completion of the quality engineering evaluation a supplemental report will be filed.

Event Description

The end-user reported that while utilizing the entree ii 5x90mm disposable trocar kit in a laparoscopic myomectomy, and after approximately 1.5 hours into the procedure the end-user noticed the 5mm entree ii cannula valve (component of the trocar kit) was damaged and a small part of the silicone valve was detached from the valve and allegedly dropped into the patient.The part that detached from the valve was reported as tiny in size and transparent and per the end-user was not removed from the patient leaving an un-retrieved device fragment within the patient.The procedure was completed without further incident and it was reported that there was no injury to the patient.

• Brand Name: ENTREE II DISPOSABLE TROCAR PROCEDURE KIT
• Type of Device: TROCAR KIT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 5513653
• MDR Text Key: 40778915
• Report Number: 1320894-2016-00017
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00653405046007
• UDI-Public: (01)00653405046007(17)200808(30)1(10)201508101
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: CD7100G
• Device Lot Number: 201508101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2015
• 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): Other