MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for PAL-650 manufactured by Microaire Surgical Instruments.
[145618953]
On april 5, 2019, pal-650/serial#: (b)(4), was subjected to internal acceptance testing. The device passed all testing and it was not possible to confirm that there were any issues with the device's functionality. A follow-up phone call between microaire formally designated complaint handling unit and a surgical technician at the user facility took place and it was reported that at times, those in charge of cleaning/sterilization are "in a rush" and do not allow their pal-650 to dry adequately. The surgical technician was instructed to follow the instructions for use associated with the device, and that not allowing adequate dry time can cause intermittent failures of the device. It is likely that the reported issue was caused by the device not being allowed to dry adequately. A review of complaint files has revealed that pal-650 is performing as expected, with regard to this failure mode.
Patient Sequence No: 1, Text Type: N, H10
[145618954]
On (b)(6) 2019, it was reported that during a liposuction procedure, a pal-650 handpiece would not function. The doctor had to perform the procedure manually until a second pal-650 device was sterilized. This delayed the surgery approximately 60 minutes. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020601-2019-00003 |
| MDR Report Key | 8511710 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-15 |
| Date Added to Maude | 2019-04-12 |
| 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. BRIAN AMELL |
| Manufacturer Street | 3590 GRAND FORKS BLVD. |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349758394 |
| Manufacturer G1 | MICROAIRE SURGICAL INSTRUMENTS |
| Manufacturer Street | 3590 GRAND FORKS BLVD. |
| Manufacturer City | CHARLOTTESVILLE VA 22911 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22911 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAL-650 |
| Generic Name | POWER ASSISTED LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-04-04 |
| Model Number | PAL-650 |
| Catalog Number | PAL-650 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROAIRE SURGICAL INSTRUMENTS |
| Manufacturer Address | 3590 GRAND FORKS BLVD. CHARLOTTESVILLE VA 22911 US 22911 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |