MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-02-18 for EURO-MED 64-488 manufactured by Coopersurgical, Inc..
[288270]
Biopsy punch tip broke off inside the patient. The doctor had to remove the broken piece manually (forceps or fingers). There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2002-00011 |
| MDR Report Key | 444310 |
| Report Source | 05,06 |
| Date Received | 2003-02-18 |
| Date of Report | 2003-02-18 |
| Date of Event | 2002-11-15 |
| Date Mfgr Received | 2002-11-26 |
| Date Added to Maude | 2003-02-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS, DIR. |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EURO-MED |
| Generic Name | KEVORKIAN BIOPSY TIP |
| Product Code | EME |
| Date Received | 2003-02-18 |
| Model Number | 64-488 |
| Catalog Number | 64-488 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 433287 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US |
| Baseline Brand Name | EURO-MED |
| Baseline Generic Name | ROTATING BIOPSY PUNCH |
| Baseline Model No | 64-488 |
| Baseline Catalog No | 64-488 |
| Baseline ID | 64-484;64-756;6 |
| Baseline Device Family | EURO-MED ROTATING BIOPSY PUNCH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K884740 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-02-18 |