MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-20 for HAR9F HAR9FRR manufactured by Stryker Sustainability Solutions Lakeland.
[182706152]
The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, evidence of clinical use was identified. The blade, jaw, teflon pad appeared to be intact. A gap near the min buttons was observed. During functional inspection, the min and max buttons were pressed and released multiple times. It was observed the min button would remain in the down position when released. There was no issues observed with the max button. Subsequently, the device was connected to a generator. Using the appropriate hand piece and pressing and releasing the min button, it was observed that the device continued to activate. The min button was observed to stick during the functional testing. While the min button was stuck, the generator alerted both visually and audibly to indicate that the device was still activating. A review of the device history record (dhr) confirmed the device met all inspection and testing requirements prior to distribution. Therefore, the most likely root causes of the reported event is handle halves separation due to improper connection of instrument to handpiece (improper torque wrench application technique used) or handling conditions subsequent to distribution from stryker. The instructions for use (ifu) state: do not torque the instrument by hand or damage may occur to the hand piece. Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece. Take care to avoid damage to the shears when removing the torque wrench from the instrument. Use the torque wrench to tighten the instrument onto the hand piece. Turn the wrench clockwise while holding the hand piece until it clicks twice, indicating that sufficient torque has been applied to secure the instrument. To ensure proper assembly, do not grip the instrument handle while applying torque with the torque wrench. Caution: do not torque the instrument by hand or damage may occur to the hand piece. Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece. Remove the torque wrench from the instrument. Do not discard the disposable torque wrench until the completion of the surgical case. The torque wrench is used for removal of the instrument from the hand piece following the procedure. In the event the torque wrench falls out of the sterile field, replace with a sterile torque wrench. Do not re-sterilize the disposable torque wrench. Caution: take care to avoid damage to the shears when removing the torque wrench from the instrument. While holding the hand piece, loosen the instrument by turning the torque wrench counterclockwise. Continue to loosen by turning the instrument manually to completely unscrew it from the hand piece. To avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable materials while not in use. 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. 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. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[182706153]
It was reported that the max button would stick and the harmonic remained activated. An alternative method was used to complete the procedure and extended procedure time reported was several minutes. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2020-00008 |
| MDR Report Key | 9732360 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-12-06 |
| Date Added to Maude | 2020-02-20 |
| 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 | 2020-02-20 |
| Returned To Mfg | 2020-02-06 |
| Model Number | HAR9F |
| Catalog Number | HAR9FRR |
| Lot Number | 11298613 |
| 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 | 1. Required No Informationntervention | 2020-02-20 |