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

Model Number 7300

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

Event Type  malfunction  

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 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
• Type of Device: ACESSA
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 7004 bee cave rd.; bldg. 3, ste. 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 7004 bee cave rd.; bldg. 3, ste. 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 8666181
• MDR Text Key: 146942394
• Report Number: 3006443171-2019-00001
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: 0100854763006140101940741817201206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1