MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-03 for CAPIO RP 832-101 * manufactured by Boston Scientific/microvasive Miami Technology Ctr..
[347836]
Needle broke off in the device during use. Resulted in a uretheral tear that had to be sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034539 |
| MDR Report Key | 570580 |
| Date Received | 2005-02-03 |
| Date of Report | 2005-01-21 |
| Date of Event | 2005-01-20 |
| Date Added to Maude | 2005-02-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO RP |
| Generic Name | RADICAL PROSTATECTOMY SUTURE CAPTURING DEVICE |
| Product Code | MCZ |
| Date Received | 2005-02-03 |
| Returned To Mfg | 2005-01-22 |
| Model Number | 832-101 |
| Catalog Number | * |
| Lot Number | 7053265 |
| ID Number | CE0197 |
| Device Expiration Date | 2007-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 560428 |
| Manufacturer | BOSTON SCIENTIFIC/MICROVASIVE MIAMI TECHNOLOGY CTR. |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-03 |