MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-21 for HARH36 HARH36RR manufactured by Stryker Sustainability Solutions Lakeland.
[145750890]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection revealed evidence of clinical use. Half of the teflon pad was melted and lifted off the actuating arm. Lifted piece of the teflon pad was not returned with the device. The jaw, blade and contact rings appear to be intact. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. Therefore, the most likely root causes are: applying pressure between instrument blade and tissue pad without having tissue between them. Prolonged activation. Repeated use of instrument beyond intended use. 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. 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 reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[145750891]
It was reported that there was a complaint on a harmonic scalpel device. No further information was known by the facility as it was reported to be unobtainable. There was no patient injury, medical intervention, or extended procedure time reported. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00028 |
| MDR Report Key | 8628885 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2019-05-21 |
| 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 | 2019-05-21 |
| Returned To Mfg | 2019-04-24 |
| Model Number | HARH36 |
| Catalog Number | HARH36RR |
| Lot Number | 9820136 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-21 |