MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-11 for NB5STF NB5STFRR manufactured by Stryker Sustainability Solutions Lakeland.
[75103654]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection of the device shows the device was returned with evidence of clinical use. The cannula showed damage to the shaft which was broken off near the cannula hub. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. Devices are rejected for any cannula shaft damage, therefore the device was unlikely to have been released from stryker with the reported failure mode. The most likely root cause is excessive force applied, contact with a hard object, or shipping/handling damage. The instructions for use (ifu) state: - these instruments are only intended for use by individuals with adequate training and familiarity with minimally invasive techniques. - prior to use, read and follow the instructions of this insert (ifu) as well as those of the instruments to be used during the procedure. Damage to the instrument can lead to patient injuries. Always inspect instrument carefully for overall integrity before use. - do not use excessive force. - careful handling of instruments is necessary to avoid damage or breakage. - inspect the instrument and package before opening. The contents of the package are sterile if the packaging has not been compromised. If the package is damaged or if ii was opened and the instrument was not used, return the instrument and packaging to stryker sustainability solutions for resterilization by ethylene oxide (eto) gas. - inspect the instruments for any damage. Do not use the instrument if any damage is noted. Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[75103655]
It was reported the trocar broke in half at the base during the procedure. Nothing fell into the patient and the device was easily removed and replaced. 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 | 0001056128-2017-00069 |
| MDR Report Key | 6562182 |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2017-05-11 |
| 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. MOIRA BARTON VARTY |
| 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 | 5307 GREAT OAK DRIVE |
| 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 | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-05-11 |
| Returned To Mfg | 2017-05-01 |
| Model Number | NB5STF |
| Catalog Number | NB5STFRR |
| Lot Number | 5483775 |
| Device Expiration Date | 2019-12-10 |
| 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 | 5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-11 |