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 2018-05-30 for AIR HOSE 5.0M AESC.-DRAEGER/AESC.SMALL GA505R manufactured by Aesculap Ag.
[109634992]
(b)(4). Manufacturing site evaluation: according to the provided information, it came to a burst of the air hose during a surgery. The surgeon suffered a temporary hearing loss. Due to a lack of components, an investigation is not possible. The device history records have been checked for the above mentioned lot number and found to be according to the specification, valid at the time of production. The failure is most probably user related. A capa is no necessary.
Patient Sequence No: 1, Text Type: N, H10
[109634993]
Country of complaint: (b)(6). It was reported that the hose bursted during the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00223 |
| MDR Report Key | 7553715 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-30 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-02 |
| Date Facility Aware | 2018-05-17 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-30 |
| 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 | AIR HOSE 5.0M AESC.-DRAEGER/AESC.SMALL |
| Generic Name | HIGH SPEED POWER SYSTEMS |
| Product Code | GET |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-05-29 |
| Model Number | GA505R |
| Catalog Number | GA505R |
| Lot Number | 51960822 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| 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 | 2018-05-30 |