ACRA CUT 200-241 DRG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-16 for ACRA CUT 200-241 DRG manufactured by Acra Cut, Inc..

Event Text Entries

[52] A disposable crainal perforator was used to make a burr hole for craniotomy. The perforator was supposed to go forward 3mm into skull but, according to the surgeon, went further, piercing the dura and stoping at the frontal lobe. Brain swelling was noticed, flap oppened and edema reduced by medication. Flap colosed and patient monitored in sicu. Originally scheduled surgery for aneurysm to be scheduled t later date when patient is deemed stable. At present, patient has returned to pre-op status. Outside lab investigating the perforator which is in progressdevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: none or unknown, none or unknown, none or unknown. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 34
• MDR Report Key: 34
• Date Received: 1992-03-16
• Date of Report: 1992-03-02
• Date of Event: 1992-02-20
• Date Facility Aware: 1992-02-20
• Report Date: 1992-03-02
• Date Reported to FDA: 1992-03-02
• Date Reported to Mfgr: 1992-02-21
• Date Added to Maude: 1992-03-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACRA CUT
• Generic Name: CRANIAL PERFORATOR
• Product Code: KAT
• Date Received: 1992-03-16
• Model Number: 200-241 DRG
• Lot Number: 1281
• ID Number: 14 MMR
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 32
• Manufacturer: ACRA CUT, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-16