MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for KAIRISON SHAFT DET. UP 235MM 4MM FK884R manufactured by Aesculap Ag & Co. Kg.
[2495417]
Device was shedding metal into wound. Facility reports they did see debris and irrigated the wound. There was no injury to the pt and the surgery was delayed only moments, if at all.
Patient Sequence No: 1, Text Type: D, B5
[9454218]
Device eval: investigation determined that the guidance of the instrument is strongly worn out. This is an unequivocal indication of insufficient lubrication. If the device is not oiled, it will come to wear. Product was according to spec; product displays improper processing. Mfr preventive and corrective measures are not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2011-00017 |
| MDR Report Key | 2386255 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-11-10 |
| Date Mfgr Received | 2011-10-10 |
| Date Added to Maude | 2012-07-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAIRISON SHAFT DET. UP 235MM 4MM |
| Product Code | HAD |
| Date Received | 2011-11-18 |
| Returned To Mfg | 2011-10-10 |
| Model Number | FK884R |
| Catalog Number | FK884R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |