MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN 1IN NEEDLE ELECTRODE WITH EXTENDED INSULATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	139105EXT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received fifteen 139105ext unopened in original packaging, the reported catalog and lot numbers were verified.Evaluations were performed on thirteen samples using aql 1.0 c=0 sampling plan procedure.A visual inspection found eleven devices with a slanted heat seal.One device had an open hole in the packaging.The packaging of one device had an open hole because the ultra clean needle punctured the packaging.A functional inspection was then performed and the devices were dye leak tested per policy.On eleven devices the dye leak test confirmed no obvious breaches, ten devices did not have any abnormalities or defects.One device had an insufficient heat seal, failing the dye leak test.The dye leaked out onto the gap caused by the slanted seal.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found no other similar events for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised that sterility is guaranteed unless package has been opened, broken, or damaged.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, ultraclean 1in needle electrode with extended insulation, catalog # 139105ext, lot 201910025, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(4).The completion of the device evaluation confirmed an insufficient heatseal.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRACLEAN 1IN NEEDLE ELECTRODE WITH EXTENDED INSULATION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11717179
• Report Number: 3007305485-2021-00167
• Device Sequence Number: 4427657
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)240930(10)201910025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 09/30/2024
• Device Model Number: 139105EXT
• Device Catalogue Number: 139105EXT
• Device Lot Number: 201910025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1