MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-25 for HARH45 HARH45RR manufactured by Stryker Sustainability Solutions Lakeland.
[143207560]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection revealed evidence of clinical use. The blade, jaw, teflon pad and contact rings appear to be intact. It was observed that the blade was not aligned with the teflon pad. The external shaft appears to be bent. The device was disassembled and inspected for cracks under a microscope. The blade coating revealed signs of erosion near a blade fracture as a result of activating against solid/hard materials. Shaft pin was found to be slightly bent. 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: jaws/blade subassembly damage; incidental and prolonged activation against solid surfaces, such as bone or plastic. The instructions for use (ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece. Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade. Do not attempt to bend, sharpen, or otherwise alter the shape of the blade. Doing so may cause blade failure and user or patient injury. Avoid contact with any and all other instruments while the instrument is activated. Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades. Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece. Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[143207561]
During a bariatric case, it was reported the harmonic scalpel (harh45) gave a "high pressure" reading on the generator. The device was replaced. The patient then came back into surgery due to internal bleeding an hour or two later. The patient was brought back for two separate open procedures after the original procedure, approximately 7 liters of blood were lost according to anesthesia. The patient received multiple transfusions. It is unknown by the facility contact if there will be additional follow-up. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00025 |
| MDR Report Key | 8553239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-10-19 |
| Date Added to Maude | 2019-04-25 |
| 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 | 2019-04-25 |
| Returned To Mfg | 2019-04-11 |
| Model Number | HARH45 |
| Catalog Number | HARH45RR |
| Lot Number | 9352677 |
| 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 | 2019-04-25 |