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

Catalog Number	CD7100G
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/17/2016
Additional 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 or Problem 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
• Common Device Name: TROCAR KIT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5513653
• Report Number: 1320894-2016-00017
• Device Sequence Number: 10845429
• Product Code: GCJ
• UDI-Device Identifier: 00653405046007
• UDI-Public: (01)00653405046007(17)200808(30)1(10)201508101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2016
• Initial Report FDA Received Date: 03/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other