MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-07-13 for T-REX BIOPSY FORCEPS FLEXIBLE, 1.8MM JAW OD, 107CM LENGTH 23468-004 manufactured by Boston Scientific.
[453261]
During a biopsy procedure, the forceps broke. The device was exchanged and the procedure was successfully completed with another forceps. No patient injuries or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000130-2005-00376 |
| MDR Report Key | 677116 |
| Report Source | 01,05,07 |
| Date Received | 2005-07-13 |
| Date of Report | 2005-06-24 |
| Date of Event | 2005-06-22 |
| Date Mfgr Received | 2005-06-24 |
| Device Manufacturer Date | 2005-02-01 |
| 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 | MICHELLE GUDITH-MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7634941194 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-REX BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2005-07-13 |
| Returned To Mfg | 2005-07-18 |
| Model Number | FLEXIBLE, 1.8MM JAW OD, 107CM LENGTH |
| Catalog Number | 23468-004 |
| Lot Number | 7454286 |
| ID Number | NA |
| Device Expiration Date | 2008-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 666404 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Baseline Brand Name | T-REX BIOPSY FORCEPS |
| Baseline Generic Name | BIOPSY FORCEPS |
| Baseline Model No | FLEXIBLE, 1.8MM |
| Baseline Catalog No | 23468-004 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-13 |