MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for 174317 174317RR manufactured by Stryker Sustainability Solutions Lakeland.
[145611278]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection of the device found evidence of clinical use on the jaws of the device. Inspection of the shaft found that the portion of the shaft that holds the shaft pin in place was missing. The returned device and packaging were inspected, no pin was found. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. The reported event could be attributed to: use error: too much force applied to the handle. Environmental disturbances: damage due to shipping, handling. The instructions for use (ifu) state: damage to the instrument can lead to injuries. Always inspect instrument carefully before use for overall integrity. Careful handling of instruments is necessary to avoid damage or breakage as a result of excessive force. Instruments were designed for cutting soft tissue. Attempting to cut staples or clips may damage the instrument. To avoid damage to patient, to operator or to instrument, become familiar with a specific instrument and its clamping or cutting mechanism prior to employing it in a surgical procedure. Close blades or jaws before attempting to withdraw instrument through the cannula. Visualize fully to avoid trapping tissue between the jaws of the instrument and causing inadvertent damage. Pull the instrument straight out through the cannula, avoiding lateral pressure that may damage the working tip. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[145611279]
It was reported a laparoscopic grasper (model 174317) broke inside the patient. The screw in the grasper portion of the tip came out. They searched for the screw but could not find it during the procedure. They confirmed via post-operation x-ray that it was left inside the patient. The extended procedure time reported was approximately 10 minutes. The screw will not be removed at this time. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00027 |
| MDR Report Key | 8625864 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-09-16 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2019-02-05 |
| Date Added to Maude | 2019-05-20 |
| 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 | 0 |
| Brand Name | NA |
| Generic Name | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
| Product Code | NWV |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-05-01 |
| Model Number | 174317 |
| Catalog Number | 174317RR |
| Lot Number | 9827332 |
| 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 | 2019-05-20 |