MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for ACCULAN II PISTOL-SHAPED BATTERY DRILL GA620D manufactured by Aesculap Ag.
[76719767]
Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u. S. (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[76719768]
(b)(6). It was reported that during surgery the drill continued to run and would not stop and the surgical nurse drilled into their fingers.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610612-2017-00291 |
MDR Report Key | 6609665 |
Date Received | 2017-06-02 |
Date of Report | 2017-06-27 |
Date Facility Aware | 2017-05-16 |
Date Mfgr Received | 2017-05-04 |
Date Added to Maude | 2017-06-02 |
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 Phone | 3145515988 |
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 | ACCULAN II PISTOL-SHAPED BATTERY DRILL |
Generic Name | POWER SYSTEMS ORTHOPAEDICS |
Product Code | NWF |
Date Received | 2017-06-02 |
Returned To Mfg | 2017-05-05 |
Model Number | GA620D |
Catalog Number | GA620D |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
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 | 2017-06-02 |