MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2002-12-19 for BONE SCOOP, F/AUTOPSY-SAW, HOLLOW, 8MM GC550R manufactured by Aesculap Ag & Co. Kg.
[285089]
Bone scoop broke during surgery. The broken piece was retrieved. Surgery was extended ten minutes. The patient did not suffer any adverse effects as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2002-00027 |
| MDR Report Key | 434857 |
| Report Source | 05,06,07 |
| Date Received | 2002-12-19 |
| Date of Report | 2002-12-17 |
| Date of Event | 2002-12-11 |
| Date Mfgr Received | 2002-12-13 |
| Date Added to Maude | 2002-12-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHY RACOSKY |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE SCOOP, F/AUTOPSY-SAW, HOLLOW, 8MM |
| Generic Name | SCOOP |
| Product Code | FHL |
| Date Received | 2002-12-19 |
| Model Number | NA |
| Catalog Number | GC550R |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 423810 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN GM 78501 |
| Baseline Brand Name | BONE SCOOP, F/AUTOPSY-SAW, HOLLOW, 8MM |
| Baseline Generic Name | SCOOP |
| Baseline Model No | NA |
| Baseline Catalog No | GC550R |
| Baseline ID | NA |
| Baseline Device Family | BONE SCOOP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-12-19 |