MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY LAP PROBE,ABC,5 MM,F/S,DISP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 160655

Device Problem Material Fragmentation (1261)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 160655, lap probe,abc,5 mm,f/s,disp, was used during a laparoscopic salpingo-oophorectomy procedure on (b)(6) 2022 when it was reported, ¿one of our lap probes broke off during a procedure and they had to retrieve the item.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The surgery was completed and the patient was reported to be healthy.Further assessment questioning found, "the patient had to switch from laparoscopic too open because the patient was bleeding a lot and not because the probe broke in the patient and when they switched to open they retrieved the fragments of the probe." the broken probe was discovered upon its removal.This report is being raised on the basis of injury due to procedure being changed from closed to open procedure.

Manufacturer Narrative

Received two devices in unoriginal package.Lot number not verified.Performed a visual inspection, the device came disassembled and damaged into three fragments.A device history record review found could not be completed as a lot number was not provided.A two-year lot history review could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 7 reports, regarding 7 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 to remove tip protector from end of probe prior to use.Inspect the probe for any damage.Do not use if you suspect any damage is present.Notify the manufacturer immediately.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LAP PROBE,ABC,5 MM,F/S,DISP
• 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 15707473
• MDR Text Key: 302771132
• Report Number: 3007305485-2022-00167
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 160655
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Ethnicity: Non Hispanic