MAUDE Adverse Event Report: INMODE LTD. FRACTORA; GEI

Model Number	AG601261A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Hyperpigmentation (4837)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Pih on face and footprint marks over the neck 2 months post treatment.
Additional Manufacturer Narrative
Following internal capa opened at inmode, voluntary reports previously submitted by inmode to fda were reviewed retrospectively.Previous voluntary report (mw5082793) was re-assessed and is reported now again as mandatory.Technical inspection of the device and the handpiece revealed no technical issues.Investigation attributed the root cause to a user error: the operator used energy settings that were too high, not congruent with the levels recommended in ifu.Spot test was not performed prior to using such aggressive parameters.The device was swapped for another device (morpheus8) and customer was retrained.

• Brand Name: FRACTORA
• Common Device Name: GEI
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17641839
• Report Number: 3010511300-2018-01003
• Device Sequence Number: 5590541
• Product Code: GEI
• UDI-Device Identifier: 07290016633054
• UDI-Public: 07290016633054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Other,Notification,Patient Monitoring,Replace
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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 Model Number: AG601261A
• Device Catalogue Number: AG601261A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White