MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-09 for HARH45 HARH45RR manufactured by Stryker Sustainability Solutions Lakeland.
[144653740]
The device was not returned to stryker sustainability solutions for evaluation. The facility stated they are working with their risk management team. The device is being held by the facility. As the device was not returned for evaluation, inspection was unable to be performed. A review of the dhr could not be performed as the lot number and/or serial number was not reported. Therefore, the most likely root causes are: user expectation of adaptive tissue technology functionality; user selects improper min settings on generator; ancillary equipment issues (e. G. Generator, handpiece, and/or adaptor); user misinterprets generator signal; tissue accumulation between the blade and shaft. The instructions for use (ifu) state: care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them. Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument. If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message. Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided. If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate. The instrument can be used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. Note: to achieve complete sealing, the trigger should be fully closed and the vessel fully contained between clamp arm and blade of device. An audible and tactile "click" indicates full trigger closure. To achieve full closure of the jaws of the device, squeeze the plastic trigger until you feel it stop against the plastic handle (plastic to plastic). If full trigger closure is released prior to or during activation on tissue, an audible and tactile "click" is evident. Increase grip force until full trigger closure is achieved. For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline. Note: do not touch the instrument to metal while activated. Note: do not clean the blade tip with abrasives. It can be wiped with a moist gauze sponge to remove tissue, if necessary. If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece. If desired, the instrument may be unplugged. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the advanced hemostasis hand control button. Do not attempt to seal vessels in excess of 7 mm in diameter. The reported event will continue to be monitored through post-market surveillance. Should the device become available for return, the investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[144653741]
It was reported the harmonic scalpel (harh45) failed, it was not sealing properly. This was noted post operation. It was stated the vessel was fully sealed during the bariatric procedure, the patient was released, but came back and the vessel was bleeding and the patient expired. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00026 |
| MDR Report Key | 8597918 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5300 REGION CT |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2019-05-09 |
| Model Number | HARH45 |
| Catalog Number | HARH45RR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |