KOMET XK- 95 TREPANMOTOR XK-95 DRILL MI-102, FOOT PEDAL MI-15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-19 for KOMET XK- 95 TREPANMOTOR XK-95 DRILL MI-102, FOOT PEDAL MI-15 manufactured by Komet Medical Surgical Power Accessories.

Event Text Entries

[139097] Neurosurgery being performed in or, physician using komet xk-95. Physician states machine did not turn off; drill went through pt's dura meter breaking cranial bone into four small pieces entering brain tissue. The acra cut cranial perforator is a disposable blade that attaches to the komet drill. It is made by a different mfr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 301409
• MDR Report Key: 301409
• Date Received: 2000-09-19
• Date of Report: 2000-09-19
• Date of Event: 2000-08-16
• Date Facility Aware: 2000-08-16
• Date Reported to Mfgr: 2000-08-16
• Date Added to Maude: 2000-10-25
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: KOMET XK- 95 TREPANMOTOR
• Generic Name: SURGICAL DRILL SYSTEM
• Product Code: KAT
• Date Received: 2000-09-19
• Model Number: XK-95
• Catalog Number: DRILL MI-102, FOOT PEDAL MI-15
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 291717
• Manufacturer: KOMET MEDICAL SURGICAL POWER ACCESSORIES
• Manufacturer Address: 800 KING GEORGE BLVD SAVANNAH GA 31419 US

Device Sequence Number: 2

• Brand Name: DGR II CRANIAL PERFORATOR
• Generic Name: DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14MMR
• Product Code: HBE
• Date Received: 2000-09-19
• Model Number: 200-251
• Catalog Number: *
• Lot Number: *
• ID Number: 3171
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 291718
• Manufacturer: ACRA CUT, INC
• Manufacturer Address: 989 MAIN STREET ACTON MA 01720 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-09-19