FDA Adverse Event
Injury
Summary report: N
AQUAMANTYS 6.0 BIPOLAR SEALER
MDR report key: 3343721
·
Received September 12, 2013
Report
- Report Number
- 1226420-2013-00167
- Event Type
- Injury
- Date Received
- September 12, 2013
- Date of Event
- June 9, 2013
- Report Date
- August 29, 2013
- Manufacturer
- MEDTRONIC ADVANCED ENERGY, LLC
- Product Code
- DWG
- PMA / PMN Number
- K052859
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(METHOD): DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED TO MANUFACTURER FOR ANALYSIS. EVALUATION CODE (RESULT): DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED TO MANUFACTURER FOR ANALYSIS. (CONCLUSION): DEVICE DISCARDED THEREFORE UNABLE TO BE RETURNED TO MANUFACTURER FOR ANALYSIS. (B)(4).
Description of Event or Problem · 1
LITERATURE COMPLAINT: BIPOLAR SEALER DEVICE REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN POSTERIOR SPINAL FUSION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS ZACHARY GORDON-MD, JOCHEN SON-HING-MD, CONNIE POE-KOCHERT-CNP, GEORGE THOMPSON-MD PUBLISHED: 6/26/2013 ADVERSE EVENT: PATIENT TREATED WITH AQUAMANTYS 6.0 BIPOLAR SEALER DEVELOPED DEEP POST-OP INFECTION. INFECTION TREATED WITH ANTI-BIOTICS AND HEALED WITHOUT FURTHER COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458894 | AQUAMANTYS 6.0 BIPOLAR SEALER | ELECTROSURGICAL DEVICE | DWG | MEDTRONIC ADVANCED ENERGY, LLC | 23-112-1 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00016 YR | Other |