MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-10 for ACESSA PROVU 7300 manufactured by Acessa Health Inc..
[175069995]
Investigation by acessa was conducted by means of follow-up communication with the patient/initial reporter, as well as the operating physician who performed the acessa procedure. Feedback from the physician stated that the patient was initially seen on (b)(6) 2019, where the risks and benefits of medication and surgery were presented to her. She also had a preoperative visit on (b)(6) 2019 where once again she was seen and discussed the options of her case and the risks and benefits of radiofrequency ablation and the acessa procedure. Physician stated the patient had the acessa procedure on (b)(6) 2019. At that time in the operative note it was noted that she had two fibroids, one around the right broad ligament slightly anterior and a second on the posterior wall. The larger right sided fibroid was 9 cm in dimension and was ablated 11 times while the small 3-4 cm posterior fibroid was ablated twice at varying depths, respectively. The physician added that the case was well treated appropriately, and that no issues or abnormalities were observed during the case. Physician stated at her post-operative visit on (b)(6) 2019, the patient presented with vague complaint of pain consistent with uterine/bladder pain. Urinalysis and urine culture were ordered, both of which returned negative. The patient was given the option of a referral to a local urogynecologist for further evaluation, but the patient did not feel that she needed to proceed with that option. Physician stated the patient returned, unscheduled, for a visit on (b)(6) 2019. The patient was seen and, again, offered a urology referral. The patient has not seen her operating physician since. Review of lot history records for the device used show no indication of non-conformance, and the device is shown to have been sterilized for single-use per the validated process. As no device was returned to acessa, further device investigation is limited. Review of acessa user's guide (pl-00-0040) identifies section 14 for potential risks of the acessa provu system, which includes pelvic pain and urinary retention. Additionally, clinical trials discussed in section 12 describe potential outcomes for efficacy, including fibroid reduction and menorrhea. Patient was contacted by acessa and the feedback from the patient stated, as of (b)(6) 2020, her symptoms persist and that she has scheduled follow up appointments with a urologist and a new obgyn. Based on the information provided thus far in this investigation, there is nothing to indicate that the patient's symptomatic claims were due to a malfunction or deficiency in manufacturing, design, or labeling of the acessa provu system. Acessa will submit a supplemental report should additional information be made available.
Patient Sequence No: 1, Text Type: N, H10
[175069996]
On (b)(6) 2019, a patient called in to the acessa patient line complaining of symptoms post-acessa procedure, which took place on (b)(6) 2019. The patient complained of bladder pain and urinary retention, as well as continued post-operative menorrhagia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2020-00001 |
| MDR Report Key | 9576166 |
| Report Source | CONSUMER |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ISAAC RODRIGUEZ |
| Manufacturer Street | 7004 BEE CAVE RD BLDG. 3, SUITE 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer Phone | 5127850707 |
| Manufacturer G1 | ACESSA HEALTH INC. |
| Manufacturer Street | 7004 BEE CAVE RD BLDG. 3, SUITE 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78746 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACESSA PROVU |
| Generic Name | ACESSA PROVU HANDPIECE |
| Product Code | HFG |
| Date Received | 2020-01-10 |
| Model Number | 7300 |
| Lot Number | MO19429B20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACESSA HEALTH INC. |
| Manufacturer Address | 7004 BEE CAVE RD BLDG. 3, SUITE 200 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-10 |