MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-07-14 for CAPIO RP 832-101 manufactured by A Division Of Boston Scientific Corp..
[17440425]
A therapeutic radical prostatectomy was performed in 2005. The needle carrier extended normally into the grooves on the distal end of the device and then separated from the proximal end while remaining in place in the grooves. The doctor withdrew the device, still containing the needle carrier, and completed the procedure successfully with another device with no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000111-2005-00013 |
| MDR Report Key | 677134 |
| Report Source | 05,06 |
| Date Received | 2005-07-14 |
| Date of Report | 2005-06-14 |
| Date of Event | 2005-06-14 |
| Date Reported to FDA | 2005-07-14 |
| Date Mfgr Received | 2005-06-14 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-02-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 8600 N.W. 41ST STREET |
| Manufacturer City | MIAMI FL 33166620 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33166 6202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO RP |
| Generic Name | SUTURING SYSTEM |
| Product Code | MCZ |
| Date Received | 2005-07-14 |
| Returned To Mfg | 2005-06-22 |
| Model Number | NA |
| Catalog Number | 832-101 |
| Lot Number | 7610081 |
| ID Number | NA |
| Device Expiration Date | 2008-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 666418 |
| Manufacturer | A DIVISION OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 8600 N.W. 41ST STREET MIAMI FL 331666202 US |
| Baseline Brand Name | CAPIO RP |
| Baseline Generic Name | SUTURING SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 832-101 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-14 |