MAUDE Adverse Event Report: CONMED MEXICO FLOVAC LAP S/I W/5MM CANNULA; SUCTION IRRIGATION

Catalog Number	60-6005-505
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported unused device was returned for evaluation in its original unopened package.Label verification and visual inspection were performed.The device inner and outer pouch packaging was observed to have holes on the poly adjacent the device's button components.This defect resulted in a breach of sterility for the device.The outer packaging defect appeared as if it was caused by a scraping motion of a blunt object.Both inner and outer pouch defects however were observed to have pieces of poly angled outward from inside the packaging; therefore, it is possible that the holes or tears may have been caused from within the packaging.Due to the appearance and location of the defects, it is possible that the device caused the damage to the packaging.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The devices released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide.Should all complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised: - inspect the package for any damage that may indicate compromised sterility or otherwise damage product this issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor in (b)(4) rejected one 60-6005-505, flovac lap s/i w/5mm cannula, due to damaged packaging.In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user.This report is raised on the basis of a device malfunction with potential for injury with reoccurrence.

• Brand Name: FLOVAC LAP S/I W/5MM CANNULA
• Common Device Name: SUCTION IRRIGATION
• Manufacturer (Section D): CONMED MEXICO; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX
• MDR Report Key: 7403782
• Report Number: 3007305485-2018-00081
• Device Sequence Number: 13468123
• Product Code: GCJ
• UDI-Device Identifier: 00653405034752
• UDI-Public: (01)00653405034752(17)191107(30)1(10)201611074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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
• Operator of Device: No Information
• Device Expiration Date: 11/07/2019
• Device Catalogue Number: 60-6005-505
• Device Lot Number: 201611074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1