MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE,BTN,HOLST,ULTRACLEAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	131309A
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 two 131309a in original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging had 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.A 2 year lot history review was conducted and found this is the only event with a quantity of 2 units for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised that sterility 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, 131309a, 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: GOLDLINE,BTN,HOLST,ULTRACLEAN
• 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: john berga ; 11311 concept blvd; largo, FL 33733 ; 7273995358
• MDR Report Key: 15560969
• Report Number: 3007305485-2022-00157
• Device Sequence Number: 5684833
• Product Code: GEI
• UDI-Device Identifier: 30653405056274
• UDI-Public: (01)30653405056274(17)260611(10)202106124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• 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
• Report Date (Section B): 10/07/2022

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: 06/11/2026
• Device Model Number: 131309A
• Device Catalogue Number: 131309A
• Device Lot Number: 202106124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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