MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 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
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 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 (b)(4) complaints, regarding (b)(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 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 the following: the user is advised that sterility guaranteed unless package has been opened, broken, or damaged.Inspect and test each device before each use.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.
Additional Manufacturer Narrative
Update: received two 139105ext in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging did not have an insufficient heat seal.Reported event of ¿insufficient heatseal¿ is unconfirmed based on device evaluation.Received two 139105ext in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging did not have an insufficient heat seal.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 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.(b)(4).Per the instructions for use, the user is advised the following: the user is advised that sterility guaranteed unless package has been opened, broken, or damaged.Inspect and test each device before each use.We will continue to monitor for trends 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.
Additional Manufacturer Narrative
Update:received two 139105ext in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging did not have an insufficient heat seal.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 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.(b)(4).Per the instructions for use, the user is advised the following: the user is advised that sterility guaranteed unless package has been opened, broken, or damaged.Inspect and test each device before each use.We will continue to monitor for trends 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 COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16267876
• Report Number: 3007305485-2023-00020
• Device Sequence Number: 20576156
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)260905(10)202109065
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2023

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: 09/05/2026
• Device Model Number: 139105EXT
• Device Catalogue Number: 139105EXT
• Device Lot Number: 202109065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 01/24/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/07/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic