MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA PROVU HANDPIECE

Model Number	7300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The handpiece was returned and evaluation confirmed that the distal tip detached from slotted tube, causing the distal tip and insulating ring to separate from the rest of the handpiece.Acessa health inc.At this time has not determined the root cause as evaluation of the returned handpiece and applicable documentation has identified that the distal tip had been attached correctly.This complaint is being reported because the distal tip of the handpiece is designed to not separate from the handpiece.This detachment happened outside of the patient so there was no possibility of patient injury.If this were to happen inside of the patient there is potential that the distal tip could remain in the treated area and require removal by the physician.
Event or Problem Description
It was reported that during a procedure the distal tip detached from slotted tube, causing the distal tip and insulating ring to separate from the rest of the handpiece.This happened outside of the patient and it was confirmed that nothing fell into the patient.The procedure was completed with a backup handpiece and there was no report of patient harm, injury, or adverse outcome.

• Brand Name: ACESSA PROVU HANDPIECE
• Common Device Name: ACESSA
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• MDR Report Key: 8666181
• Report Number: 3006443171-2019-00001
• Device Sequence Number: 19410376
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: 0100854763006140101940741817201206
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: 7300
• Device Lot Number: 19407418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1