MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for ACESSA GUIDANCE HANDPIECE 5300 manufactured by Acessa Health Inc..
[95322048]
Device not available for investigation or testing, therefore root cause analysis of device was not possible. Hazard analysis (fa-01-0003-q. I. D. 94) describes a possible hazard with packaging being compromised prior to use resulting in contamination of device and patient fever. This is highly unlikely as standard of care requires users to evaluate packaging prior to use. The ifu states do not use if product or packaging is damaged (pl-01-0033-f). Email update was received on (b)(6) 2017 from (b)(6) that stated: "currently the patient is doing well and has had no sequelae after her recovery. "
Patient Sequence No: 1, Text Type: N, H10
[95322049]
Patient re-admitted to hospital 3 days following novasure/acessa procedure with heavy bleeding and low grade fever. While in the hospital, bleeding was controlled and patient was found to have uti. Patient was treated with anti-biotic and discharged. Patient returned 2 days later with low grade fever again. White blood cell count was elevated. Ct scan showed nothing of consequence. On (b)(6) 2017 patient discharged again. Patient woke up on (b)(6) 2017 with low grade fever and is being monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2017-00001 |
| MDR Report Key | 7131218 |
| Date Received | 2017-12-19 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-12-19 |
| 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 | MR. ISAAC RODRIGUEZ |
| Manufacturer Street | 7004 BEE CAVE RD. BLDG. 3, STE. 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, STE. 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 | 0 |
| Brand Name | ACESSA GUIDANCE HANDPIECE |
| Generic Name | ACESSA |
| Product Code | HFG |
| Date Received | 2017-12-19 |
| Model Number | 5300 |
| Catalog Number | 5300 |
| Lot Number | 17051 |
| Operator | PHYSICIAN |
| 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, STE. 200 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-19 |