MAUDE Adverse Event Report: HOLOGIC / ACESSA HEALTH INC. ACESSA PROVU GENERATOR; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Activation Failure (3270)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2021

Event Type  Injury  

Event Description

Provider was performing a laparoscopic removal and ablation of intrauterine fibroids using the acessa provu generator and handpiece.Two manufacturer representatives were present.Mid-procedure the provider attempted to activate the ablation probe, but the acessa provu generator failed to function.The hologic representative attempted to troubleshoot the generator but was unable to reach a solution.The failure resulted in the provider being unable to remove all of the intended fibroids which may require the patient to undergo a second surgical procedure.Fda safety report id # (b)(4).

• Brand Name: ACESSA PROVU GENERATOR
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC / ACESSA HEALTH INC.; marlborough MA 01752
• MDR Report Key: 12384883
• MDR Text Key: 268963947
• Report Number: MW5103568
• Device Sequence Number: 1
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/25/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Weight: 76