MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for ACESSA PROVU HANDPIECE 7300 manufactured by Acessa Health Inc..
[188486317]
Additional details of the patient's acessa procedure were collected both from the physician and the acessa clinical representative who was in attendance on the date of the case. It was reported that, during placement of the first 5 mm trocar for the laparoscope port, the physician punctured the patient's uterus, causing uncontrolled bleeding in the cavity. The physician attempted to control bleeding during the case, but ultimately the puncture necessitated a hemostatic agent to help control bleeding and allowed for the continuation of the case. The case consisted of treatment of one 6 cm fibroid that was ablated 4 times for a total of 12 minutes. The patient had no issues or preexisting conditions that acessa has been made aware of. No further complications were reported concerning the acessa portion of the case. Lot records for the single-use handpiece show that the handpiece in use was sterilized properly per validated process. All other reprocessed equipment used in the case were also reported to have been sterilized per process. Additionally, all devices in use were reported to have been inspected prior to the case with no sign of abnormalities with the product(s) or product packaging. As no device was collected or returned to acessa as a part of this field complaint, further investigation is limited. Based on the information provided concerning the case in which the acessa procedure was performed, as well as the lot records for the handpiece used, there is nothing to indicate that any component of the acessa provu system would have caused the patient's post-operative infection. However, the uterine puncture prior to the use of acessa and subsequent bleeding may have contributed to this condition. As described in the acessa provu user's guide (pl-01-0040-a), the acessa provu system is intended for use under standard laparoscopy. However, the laparoscope itself, as well as any trocars used to place all equipment ports, are not considered to be a part of the acessa provu system. Therefore, organ puncture is considered to be a risk of general laparoscopic surgery and not an inherent risk of the acessa procedure. As such, acessa is making this report only out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[188486318]
Acessa health was notified by a physician on 12/11/2019 that their patient was having complications post-acessa procedure, which was performed on (b)(6) 2019. The physician stated that the patient was re-admitted to the hospital 3 days post-op to treat a suspected infection, identified by an elevated white blood cell (wbc) count. After several rounds of antibiotics were unsuccessful at stabilizing the patient's wbc count, and with the physician fearsome of sepsis, the physician made the decision to perform a hysterectomy, on (b)(6) 2019, to eliminate the source of infection. Patient is reported to be doing well after her hysterectomy, having been discharged from the hospital four days after the procedure with stable blood count.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2019-00005 |
| MDR Report Key | 9540889 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-01-02 |
| 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 HANDPIECE |
| Generic Name | ACESSA PROVU |
| Product Code | HFG |
| Date Received | 2020-01-02 |
| Model Number | 7300 |
| Lot Number | 19857867 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-02 |