MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for HUDSON CHUCK F/GB102R/GB169R/GA522R GB106R manufactured by Aesculap Ag.
[166156118]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[166156119]
It was reported that there was an issue with the product hudson chuck f/gb102r/gb169r/ga522r. During burhole surgery (left temporalcraniotomy) when the craniotome blade reached the hematoma, the blade injured the patients dura mater. An additional medical intervention was necessary. The injury was sutured by the surgeon, and , by suturing the injured part, it took extra time in the surgical procedure (not known how long). The procedure was finished and, so far , there has not been any further complications to the patient reported to us. The surgeon stated that the blade injured the dura mater, probably because of the thin skull, but he wants to have the device checked to see if there was any defect. The adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 400443989_9610612-2019-00661, 400443990_9610612-2019-00662, 400443991_9610612-2019-00664.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00663 |
| MDR Report Key | 9124647 |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-08-30 |
| Date Mfgr Received | 2019-08-30 |
| Date Added to Maude | 2019-09-26 |
| 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 |
| 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 | 0 |
| Brand Name | HUDSON CHUCK F/GB102R/GB169R/GA522R |
| Generic Name | POWER SYSTEMS |
| Product Code | HXY |
| Date Received | 2019-09-26 |
| Model Number | GB106R |
| Catalog Number | GB106R |
| 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 | 1. Required No Informationntervention | 2019-09-26 |