MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN ELEC:6"BLDE EXT IN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	139110EXT
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 device is expected to be returned for evaluation.A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.
Event or Problem Description
The distributor in (b)(4) rejected one 139110ext, ultraclean elect: 6"blde ext in, due to an "insufficient heatseal".In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user.The report is raised on the basis of a device malfunction with potential for injury with reocurrence.
Additional Manufacturer Narrative
Devices were received in unopened, original packaging.The catalog and lot numbers were verified.All returned devices were inspected for seal integrity.Inspection found that the seal width was less than 1/4 inch.This defect was likely caused by the device pushing into the seal area during shipping.All devices were tested for sterility breach by dye leak testing.Testing found three of the six samples had sustained a breach in sterility by means of a channel on the non-chevron side of the seal.This defect would be caused during the sealing process.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint, quantity of 6, for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 21 complaints, regarding 57 devices, for this device family and failure mode.During this same time frame 2,454,942 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00002.Per the instructions for use, the user is advised the following: contraindications: -these devices should never be used when: - there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic - these devices fail the inspection described herein safety tips: - inspect and test each device before use inspection: - these devices should be inspected before each use.Visually examine the devices for obvious physical damage including: - cracked, broken or otherwise distorted plastic parts - damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN ELEC:6"BLDE EXT IN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 7522431
• Report Number: 3007305485-2018-00114
• Device Sequence Number: 1333389
• Product Code: GEI
• UDI-Device Identifier: 40653405007341
• UDI-Public: (01)40653405007341(17)220718(10)201707194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• 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,Followup
• Report Date (Section B): 06/08/2018

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: Other
• Device Expiration Date: 07/18/2022
• Device Model Number: 139110EXT
• Device Catalogue Number: 139110EXT
• Device Lot Number: 201707194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1