MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE SINGLE USE CANNULA; 3MM SINGLE USE CANNULA

Model Number PAL-30MLM

Device Problem Fracture (1260)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Doctor performing bilateral breast fat grafting.While preforming the fat grafting, doctor noted something looked off with the fat grafting cannula mid use and realized the tip was missing.Rn circulator, informed charge nurse of the situation and called for an x-ray at 1004.Or manager notified by charge nurse.X-ray taken and revealed broken tip of cannula in patient's back.Tip was removed by doctor easily and in one piece.Repeat x-ray showed no retained instrument fragments.X-ray read by radiologist at 1022 and confirmed that the piece had been removed.Doctor observed retrieved tip an compared it to the cannula handle - confirmed that all pieces were accounted for.Or manager retrieved packaging from trash with reference and lot numbers and also notified or director.

• Brand Name: MICROAIRE SINGLE USE CANNULA
• Type of Device: 3MM SINGLE USE CANNULA
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 15478595
• MDR Text Key: 306184905
• Report Number: 2020601-2022-00004
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 00847399008312
• UDI-Public: (01)00847399008312
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PAL-30MLM
• Device Catalogue Number: PAL-30MLM
• Device Lot Number: 02222368185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention