MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-07 for STRYKER MPN 377-031-630 manufactured by .
[1140335]
While doing shoulder arthroscopy, md noticed a foreign object in patient's joint. It was retrieved with a grasper and found to be a portion of rubber "o" ring. It was determined to be the inner lumen of a reusable stryker cannula used during this surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011043 |
| MDR Report Key | 1378546 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-05-07 |
| Date of Event | 2009-05-01 |
| Date Added to Maude | 2009-05-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER |
| Generic Name | CANNULA |
| Product Code | KOG |
| Date Received | 2009-05-07 |
| Model Number | MPN 377-031-630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | STRYKER OBTURATOR |
| Generic Name | NONE |
| Product Code | FEC |
| Date Received | 2009-05-07 |
| Model Number | MPN 677-031-610 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-07 |