MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for UNK_SUS manufactured by Stryker Sustainability Solutions Lakeland.
[61020075]
The device was not returned to stryker sustainability solutions for evaluation. The facility misplaced the device. As the device was not returned for evaluation, visual and functional inspection was unable to be performed. A review of the dhr could not be performed as the lot number was not reported. The reported event could be attributed to insufficient structural integrity and damage to the device during shipping and handling. Should the device become available for return, the investigation will be reopened. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[61020076]
It was reported the trocar broke apart. When taken out of the packaging, it fell apart. The issue was noticed prior to incision and nothing fell into the patient. The device was replaced with another trocar. 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 | 0001056128-2016-00152 |
| MDR Report Key | 6123242 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-09-02 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2016-11-22 |
| 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 | 2016-11-22 |
| Catalog Number | UNK_SUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-22 |