MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE®; SYSTEM, SUCTION, LIPOPLASTY

Model Number	PAL-30MLM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor performing bilateral breast fat grafting.While performing 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 situation and called for an x-ray at 1004.Operating room 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 and 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 operating room director.

• Brand Name: MICROAIRE®
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; 3590 grand forks blvd; charlottesville PA 22911
• MDR Report Key: 15265974
• Report Number: 15265974
• Device Sequence Number: 5881129
• Product Code: MUU
• UDI-Device Identifier: 00847399008312
• UDI-Public: (01)00847399008312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/17/2022
• Report Date (Section F): 08/17/2022

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: Health Professional
• Device Model Number: PAL-30MLM
• Device Catalogue Number: PAL-30MLM
• Device Lot Number: 0222368185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/17/2022