MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRACLEAN 1 IN. BLADE EXTND INSULATN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 139104EXT

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During incoming inspection, the distributor rejected this device, 139104ext, 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.

Manufacturer Narrative

Received one 139104ext in unopened original packaging.Lot number was verified.Performed a visual inspection, the device is protruding through the seal.A likely cause for this issue is damage during shipping and handling.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 288 complaints, regarding 8,508 devices, for this device family and failure mode.During this same time frame 8,644,952 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 0.001.Per the instructions for use, the user is advised the following: sterility is guaranteed unless package has been opened, broken or damaged.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN 1 IN. BLADE EXTND INSULATN
• Type of Device: 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 33773 ; 7273995358
• MDR Report Key: 18362914
• MDR Text Key: 330960828
• Report Number: 3007305485-2023-00252
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 40653405007198
• UDI-Public: (01)40653405007198(17)270516(10)202205175
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 139104EXT
• Device Lot Number: 202205175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic