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 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the device, the complaint was confirmed.Though investigation details from the initial reporter were not specific about an observed event, it can be inferred that the operating physician either neglected the pre-surgery device inspection or, during the case, damaged the acoustic lens of the provu transducer (7700) with the sharp distal mandrel of the accessory provu handpiece (7300).In either case, investigation has determined the cause to be use error.The operating physician was a new physician to the acessa procedure.The cavity was suctioned and cleared, and no additional surgical intervention was required.A review of the acessa provu transducer ifu (pl-01-0044 rev.Instructs users to perform a device inspection prior to use of the device, including "verify the insertion area of the transducer is free from holds, dents, scratches, cracks, deformations and color changes on the surface." users are instructed not to use the device if it does not pass this inspection.Additionally, review of the provu handpiece ifu (pl-01-0038 rev.Instructs users of caution for the sharp distal tip in the "warnings" section.Although the cavity was suctioned and cleared, and we are 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 6/20/2019, it was reported that about 75% through a case, that the acessa provu transducer with sensor (7700) was identified as having a surface defect on the silicone acoustic lens of the transducer.Prior to that point in the case, neither the operating physician nor any member of the surgical staff had observed any damage to the transducer.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: 8804606
• MDR Text Key: 209362875
• Report Number: 3006443171-2019-00004
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006188
• UDI-Public: (01)00854763006188(10)190206
• 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: 07/18/2019

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: 190206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/18/2019
• 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