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

Model Number	7700
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPIC ULTRAOUND TRANSUDCER
• Manufacturer (Section D): ACESSA HEALTH INC.; 7004 bee cave rd; bldg. 3, suite 200; austin TX 78746
• MDR Report Key: 8761571
• Report Number: 3006443171-2019-00003
• Device Sequence Number: 2040142
• Product Code: HFG
• UDI-Device Identifier: 00854763006188
• UDI-Public: (01)00854763006188(10)181122
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1