MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-16 for KAIRISON PNEUM.PUNCH PRESSURE REDUCER FK898R manufactured by Aesculap Ag.
[117438995]
Investigation: the investigation was carried out visually and a functional test was performed. The connectin pins are no longer according to the specifications, since they are deformed, most likely caused by a drop. Due to these damages, a proper mounting of the disposable tube set fk888su can no longer be guaranteed. The functional test was carried out successfully, but the set could only be assembled with high forces. Without a correct connection of the tube set, the function of the kairison bone punch will not be according to specification. Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient usage. No capa is necessary.
Patient Sequence No: 1, Text Type: N, H10
[117438996]
Country of complaint: (b)(6). Io would not engage shaft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00311 |
| MDR Report Key | 7790280 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-16 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-07-06 |
| Date Facility Aware | 2018-07-16 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-08-16 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO 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 PNEUM.PUNCH PRESSURE REDUCER |
| Generic Name | RONGEUR, POWERED |
| Product Code | HAD |
| Date Received | 2018-08-16 |
| Returned To Mfg | 2018-07-24 |
| Model Number | FK898R |
| Catalog Number | FK898R |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-16 |