MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-03-21 for 11G IVAS ACCESS CANNULA 0306330000 manufactured by Stryker Instruments-kalamazoo.
[70514603]
It was reported that during the procedure the handle of the access cannula separated from the needle which left the cannula in the patient. However, the cannula was successfully removed. A scan was performed to ensure no device material remained in the patient. The procedure was completed successfully without a clinically significant delay and no additional medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[115070245]
Patient Sequence No: 1, Text Type: N, H10
[115070246]
It was reported that during the procedure the handle of the access cannula separated from the needle which left the cannula in the patient. However, the cannula was successfully removed. A scan was performed to ensure no device material remained in the patient. The procedure was completed successfully without a clinically significant delay and no additional medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-00780 |
| MDR Report Key | 6422787 |
| Report Source | OTHER |
| Date Received | 2017-03-21 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 |
| Manufacturer City | ARROYO 00615 |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11G IVAS ACCESS CANNULA |
| Generic Name | INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) |
| Product Code | OAR |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-03-20 |
| Catalog Number | 0306330000 |
| 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 INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-21 |