MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRCLN 1 IN. NEDL W/EXTND 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
Received three (3)139105ext unopened in original packaging.The lot number of the devices - 201910285 was verified.A visual inspection found one device encroaching into the seal of the packaging, second device had a small unsealed portion on the packaging on top of the heatseal, third device has a slanted seal with a gap.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging of one device had an insufficient heat seal.The dye leaked into the gap caused by the device encroaching into the seal.Two other devices did not have any leaks.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.A non-conformance was found; however, it did not contribute to this issue.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint 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 71 complaints, regarding 236 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised: sterility guaranteed unless package has been opened, broken, or damaged.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.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, 139105ext, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRCLN 1 IN. NEDL W/EXTND INSULATION
• 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: 11856393
• Report Number: 3007305485-2021-00228
• Device Sequence Number: 17308920
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)241026(10)201910285
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: Other
• Device Expiration Date: 10/26/2024
• Device Model Number: 139105EXT
• Device Catalogue Number: 139105EXT
• Device Lot Number: 201910285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1