MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for AQUAMANTYS 6.0 BIPOLAR SEALER 23-112-1 manufactured by Medtronic Advanced Energy, Llc.
[19612909]
Patient had total left hip arthroplasty (b)(6) with the use of the aquamantys 6. 0 bipolar sealer, (b)(4), used for hemostasis. Patient sustained a right hip burn secondary to leaking of saline from the disposable end piece of the equipment. The lot # was not noted but we have two lot#'s in stock pha065bn0 and pha175l0. Of interest the user manual does suggest when not in use the end piece is stored in a holster or table outside of surgical area to prevent leaking. Not holster is supplied and there is no warning on disposable end piece of that nature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042641 |
| MDR Report Key | 4768758 |
| Date Received | 2015-05-08 |
| Date Added to Maude | 2015-05-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUAMANTYS 6.0 BIPOLAR SEALER |
| Generic Name | AQUAMANTYS 6.0 BIPOLAR SEALER |
| Product Code | DWG |
| Date Received | 2015-05-08 |
| Model Number | 23-112-1 |
| Catalog Number | 23-112-1 |
| Lot Number | IT2 UNIC |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Brand Name | DISPOSABLE END PIECE |
| Generic Name | DISPOSABLE END PIECE |
| Product Code | GCJ |
| Date Received | 2015-05-08 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-05-08 |