MAUDE Adverse Event Report: LIPOGEMS INTERNATIONAL SPA LIPOGEMS PROCESS DEVICE; SPORT MEDICINE 240

Model Number	LGD 240
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Compliant was reviewed and deemed reportable during 2019 audit.The infiltration cannula was not properly handled, per the ifu.Failure to follow manufacturer's instruction for use during the initial insertion by the surgeon, and reusing the same cannula after noting that it was bent, was cause of the tip being broken in the patient.Excessive force was used during surgeon's initial insertion causing it to bend.There was a second cannula opened to replace the bent one, however the surgeon again used the bent cannula on the patient and the tip broke off.Infiltration cannula tip was left in the patient at discretion of the surgeon.The surgeon has advised that he did inform the patient of the situation and in his professional opinion did not feel that the piece remaining inside would be a problem.

• Brand Name: LIPOGEMS PROCESS DEVICE
• Common Device Name: SPORT MEDICINE 240
• Manufacturer (Section D): LIPOGEMS INTERNATIONAL SPA; viale bianca maria, 24; milan, 20129 ; IT 20129
• MDR Report Key: 8937292
• Report Number: 3006053983-2019-00001
• Device Sequence Number: 525910
• Product Code: MUU
• UDI-Device Identifier: 08058773562432
• UDI-Public: 08058773562432
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: LGD 240
• Device Catalogue Number: LG MK 240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2018
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other