MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-06-27 for T-REX BIOPSY FORCEPS H749234670010 manufactured by Boston Scientific.
[490665]
It was reported that during an unspecified diagnostic procedure, forceps removal difficulty occurred. The t-rex biopsy forceps wire broke, leaving the jaws in an open position, making it "impossible" to remove the device from the patient. With the use of a hemostat, the physician was able to grab the wires, close the jaws, and remove the t-rex biopsy forceps from the patient. Current patient status is reported as "okay". The procedure was successfully completed with another t-rex biopsy forceps.
Patient Sequence No: 1, Text Type: D, B5
[7781435]
The device has not been returned for analysis as of the date of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000130-2006-00158 |
| MDR Report Key | 734375 |
| Report Source | 05,07 |
| Date Received | 2006-06-27 |
| Date of Report | 2006-06-01 |
| Date of Event | 2006-05-31 |
| Date Mfgr Received | 2006-06-01 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2006-07-17 |
| 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 | MARK GAYLE - MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7632550529 |
| 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 | 2006-06-27 |
| Model Number | NA |
| Catalog Number | H749234670010 |
| Lot Number | 8444638 |
| ID Number | NA |
| Device Expiration Date | 2009-02-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 722246 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Baseline Brand Name | T-REX BIPSY FORCEPS |
| Baseline Model No | NA |
| Baseline Catalog No | H749234670010 |
| Baseline ID | NA |
| Baseline Device Family | BIOPSY FORCEPS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000409 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-27 |