MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for MICROAIRE CANNULA PAL-R30MLL manufactured by Microaire Surgical Instruments.
[133944713]
Reference failure analysis (fa-2020601-2018-00011).
Patient Sequence No: 1, Text Type: N, H10
[133944714]
It was reported that on (b)(6) 2018 while patient was undergoing liposuction of the flanks under general anesthesia, a 3mm liposuction cannula tip broke off at the last set of holes inside the patient's left flank. This was noted and attempts at palpating and finding the tip intraoperatively without making an incision were unsuccessful. An ultrasonic examination was performed to locate the exact location. Under sterile conditions and sedation, a 1. 5cm incision was made and the cannula tip was removed intact on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020601-2018-00011 |
| MDR Report Key | 8258986 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2012-04-05 |
| Date Added to Maude | 2019-01-17 |
| 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 22911 |
| Manufacturer Country | US |
| Manufacturer Postal | 22911 |
| 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 | MICROAIRE CANNULA |
| Generic Name | 3.0MM MULTI-USE CANNULA |
| Product Code | MUU |
| Date Received | 2019-01-17 |
| Returned To Mfg | 2018-12-19 |
| Model Number | PAL-R30MLL |
| Catalog Number | PAL-R30MLL |
| Lot Number | 0412200488 |
| 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 | 2019-01-17 |