MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-08 for HARH36 HARH36RR manufactured by Stryker Sustainability Solutions Lakeland.
[182705758]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection revealed evidence of clinical use. The teflon pad was identified to be melted; however, the teflon pad was attached to the jaw. The blade, jaw, handle, 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. Due to the device being returned with a melted teflon pad, cutting and sealing tissue was unable to be assessed. Therefore, the most likely root causes are: applying pressure between instrument blade and tissue pad without having tissue between them repeated use of instrument beyond intended use. Tissue accumulation between the blade and shaft. Prolonged activation (in general or against solid surfaces). User selects improper min generator settings. User activates on max instead of min. 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 happens, there may be a system failure signaled by a continuous tone or alert screen when either of the foot pedals or hand control buttons is depressed. Keep the jaws of the device open when backcutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm, and distal shaft temperatures. Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence or timing of the tone change. Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft. To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft. During and following activation in tissue, the instrument blade and clamp arm may become hot. Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times. Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[182705759]
It was reported there was an issue with a harmonic device which caused the patient to bleed a lot, resulting in changing to an open procedure. It is unknown if there was any patient injury or extended procedure time. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2020-00003 |
| MDR Report Key | 9566458 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-08 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-09-07 |
| Date Added to Maude | 2020-01-08 |
| 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 | 2020-01-08 |
| Returned To Mfg | 2019-12-19 |
| Model Number | HARH36 |
| Catalog Number | HARH36RR |
| Lot Number | 10849813 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-08 |