MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA PROVU TRANSDUCER; LAPAROSCOPIC ULTRAOUND TRANSUDCER

Model Number 7700

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the device, the complaint was confirmed.Investigation of the complaint determined the cause to be use error.The operating physician was new to the acessa procedure, and the incident reported in this complaint occurred during a proctored case (physician training).The cavity was suctioned and cleared, and no additional surgical intervention was required.A review of the acessa provu handpiece ifu (pl-01-0038 rev.B) instructs users of caution for the sharp distal tip in the "warnings" section.Although, the cavity was suctioned and cleared, and the operating physician was confident that there was no debris left, this report is being made out of an abundance of caution because, in general, if debris remains present in a patient, it could possibly necessitate medical or surgical intervention.

Event Description

On 6/7/2019, it was reported that during a case, the acessa provu handpiece (7300) made contact with the acessa provu transducer with sensor's (7700) acoustic lens.The operating physician inadvertently made contact between the distal tip of the handpiece and the silicone lens of the transducer.The contact of the sharp distal mandrel of the handpiece with the silicone scanning window resulted in damage to the silicone layer of the lens in two separate locations.Upon recognition of the damaged silicone, the cavity was suctioned and cleared to ensure removal of any potential debris, with a statement of confidence from the operating physician stating that the cavity had been appropriately cleared.The case was completed successfully, there was no reported harm, injury, adverse outcome, or patient complications.

• Brand Name: ACESSA PROVU TRANSDUCER
• Type of Device: LAPAROSCOPIC ULTRAOUND TRANSUDCER
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd; bldg. 3, suite 200; austin TX 78746
• Manufacturer (Section G): ACESSA HEALTH INC.; 7004 bee cave rd; bldg.3, suite 200; austin TX 78746
• Manufacturer Contact: isaac rodriguez ; 7004 bee cave rd; bldg. 3, suite 200; austin, TX 78746 ; 5127850707
• MDR Report Key: 8761571
• MDR Text Key: 191020868
• Report Number: 3006443171-2019-00003
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006188
• UDI-Public: (01)00854763006188(10)181122
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/03/2019

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
• Device Operator: Health Professional
• Device Model Number: 7700
• Device Lot Number: 181122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1