MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for AESCULAP KERRISON 281-061 manufactured by Aesculap, Inc..
[85636384]
Patient Sequence No: 1, Text Type: N, H10
[85636385]
At the beginning of the procedure, the kerrison #3 bone punch fell apart before use on the patient, and the screw was noted to be missing. The item was removed from service immediately after all pieces were collected. The mobile repair services inspected the instrument and determined that all pieces in fact were present. It is believed that the failure occurred due to normal wear and tear. The age of the item is approximately 15 years. The instrument was repaired by mobile repair tech and deemed appropriate for use. The item was permanently removed from service and new devices were ordered (b)(6). Manufacturer response for surgical instrument, aesculap kerrison (per site reporter). Mobile repair serves inspected the instrument and determined that all pieces were present. It is believed that this occurred from normal wear and tear. The approximate age of the device is 15 years. The instrument was repaired by the mobile repair tech and deemed appropriate to use. However, the item was permanently removed from service and new kerrison's were ordered (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6854555 |
| MDR Report Key | 6854555 |
| Date Received | 2017-09-11 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-03-09 |
| Report Date | 2017-08-25 |
| Date Reported to FDA | 2017-08-25 |
| Date Reported to Mfgr | 2017-08-25 |
| Date Added to Maude | 2017-09-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AESCULAP KERRISON |
| Generic Name | RONGEUR, POWERED |
| Product Code | HAD |
| Date Received | 2017-09-11 |
| Model Number | 281-061 |
| Catalog Number | 281-061 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-11 |