MAUDE Adverse Event Report: CONMED CORPORATION CORE ENTREE II 5-12MM VALVE REDUCER; VALVE/REDUCER

Catalog Number	CD775
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received one (1) "used/damaged" core entree ii valve/reducer for evaluation, as well as 19 unopened lot sample devices.The "used/damaged" device was received with the bottom portion of the main body reducer/seal torn completely off.The tear occurred along the upper proximal lycra fabric line.It was noted that the fabric line was not uniform/circular and the position of the fabric near the distal hole showed inconsistency.A divot was also noted at each of the three molding gate locations.Nineteen (19) cd775 devices were received in unopened packages with lot #201506081.Again, on all of the devices, the fabric line was not uniform/circular and the position of the fabric near the distal hole showed inconsistency.However, it is unknown if any of these observations would have caused tearing of the seal.The physical damage of the seal gave an indication that the cause of detached seal was most likely use related.The specific instruments used in the procedure when the incident occurred are unknown.The devices were manufactured on 08-jun-2015.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.(b)(4).To date there have been no patient long term adverse effects reported regarding these incidents.The 5-12mm entree ii valve/reducer is comprised of an internal silicone valve and reducer contained in a plastic housing.When attached to a compatible cannula, it allows the insertion of multi-sized instrumentation and prevents co2 gas loss.The entree ii valve/reducer, available in 5-12mm size has application in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.To prevent damage to the device and leakage, the instructions for use (ifu) provides the following precautions and warnings: to prevent damage, the trocar should not be introduced into the valve/reducer at an angel.Sharp instrumentation may compromise the elastic seal.Desufflation will occur during instrument insertions if the elastic seal is compromised.
Event or Problem Description
The end-user facility reported that during use of a cd775 core entree 5-12mm valve/reducer in a laparoscopic procedure, the inner plastic valve become dislodged and fell into the patient's peritoneal cavity.The valve was immediately retrieved and removed from the patient's peritoneal cavity.The surgeon replaced the device and the procedure was completed without further incident.As reported, the procedure was completed with no patient injury as a result of the reported event.To date, there has been no additional information received regarding the patient's latest condition or any indication that any long term adverse effect has occurred.

• Brand Name: CORE ENTREE II 5-12MM VALVE REDUCER
• Common Device Name: VALVE/REDUCER
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5644559
• Report Number: 1320894-2016-00045
• Device Sequence Number: 293496
• Product Code: HET
• UDI-Device Identifier: 00653405046168
• UDI-Public: (01)00653405046168(17)200606(30)1(10)201506081
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K950457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: CD775
• Device Lot Number: 201506081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/10/2016
• 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