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 2020-02-26 for KAIRISON PNEUM.PUNCH HANDLE FK899R manufactured by Aesculap Ag.
[184321432]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if received.
Patient Sequence No: 1, Text Type: N, H10
[184321433]
It was reported that there was an issue with a kairison pneum. Punch handle. It was reported that when the surgeon pulled the trigger, the hand piece "exploded". A second set/tray was pulled to be utilized in surgery. The type of surgery was a laminectomy. There was no patient harm. An additional medical intervention was not necessary. This malfunction prolonged the surgery for 30 minutes. Additional information has been requested but not yet received as of this report. The malfunction is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00997 |
| MDR Report Key | 9758276 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2019-12-03 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 HANDLE |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HAD |
| Date Received | 2020-02-26 |
| Model Number | FK899R |
| Catalog Number | FK899R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-26 |