MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE,BTN,HOLS,EXT.BLADE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 138114A

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

Received two 138114a in original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal.Performed a function inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that one out of the two devices 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.(b)(4).Per the instructions for use, the user is advised to inspect and test each device before use.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

During incoming inspection, the distributor rejected this device, 138114a, 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,HOLS,EXT.BLADE
• 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: 15824244
• MDR Text Key: 304031605
• Report Number: 3007305485-2022-00176
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405056298
• UDI-Public: (01)30653405056298(17)260616(10)202106174
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K791137
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 138114A
• Device Catalogue Number: 138114A
• Device Lot Number: 202106174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic