MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-02-29 for ACKERMANN BONE BIOPSY NEEDLE SET N/A ABC-200 manufactured by Cook Inc.
[39285964]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[39285965]
Information was received on 05feb2016 through (b)(4): a bone biopsy was the procedure. The physician went to remove the needle and the handle broke off. Leaving the trocar behind in the patient. After a few attempts from the performing physician, a consult was made to neuro surgery. Neuro surgery physician arrived and successfully removed the trocar.
Patient Sequence No: 1, Text Type: D, B5
[47819521]
(b)(4). Investigation - evaluation: a review of complaint history and quality control was conducted during the investigation. Based on the information provided and the results of our investigation, a definitive root cause could not be determined. Since product was not returned for investigation it is difficult to determine the root cause. There is no evidence to suggest the product was not manufactured to current specifications. A definitive root cause could not be determined. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints. Per the quality engineering risk assessment (qera) no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[47819522]
Information was received on 05feb2016 through medsun report #(b)(4): a bone biopsy was the procedure. The physician went to remove the needle and the handle broke off. Leaving the trocar behind in the patient. After a few attempts from the performing physician, a consult was made to neuro surgery. Neuro surgery physician arrived and successfully removed the trocar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00093 |
| MDR Report Key | 5467413 |
| Report Source | OTHER |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-19 |
| Date Facility Aware | 2016-01-19 |
| Report Date | 2016-01-27 |
| Date Reported to FDA | 2016-01-27 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2016-02-29 |
| 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 | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACKERMANN BONE BIOPSY NEEDLE SET |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2016-02-29 |
| Model Number | N/A |
| Catalog Number | ABC-200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 20 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-29 |