DEPUY GIGLI SAW BLADE * 6560-14-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-27 for DEPUY GIGLI SAW BLADE * 6560-14-000 manufactured by Depuy, Inc..

Event Text Entries

[166968] Pt having surgery on brain tumor. Wires on the gigli saw blades were fractured, causing a cut in the brain itself.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 283576
• MDR Report Key: 283576
• Date Received: 2000-06-27
• Date of Report: 2000-06-27
• Date of Event: 2000-06-13
• Date Facility Aware: 2000-06-14
• Report Date: 2000-06-27
• Date Reported to Mfgr: 2000-06-27
• Date Added to Maude: 2000-06-29
• 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 Details

• Brand Name: DEPUY GIGLI SAW BLADE
• Generic Name: GIGLI 20" SAW BLADE
• Product Code: HSO
• Date Received: 2000-06-27
• Model Number: *
• Catalog Number: 6560-14-000
• Lot Number: UC6E61000
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 274417
• Manufacturer: DEPUY, INC.
• Manufacturer Address: P.O. BOX 988 WARSAW IN 46581 US
• Baseline Brand Name: STERILE GIGLI SAW 20
• Baseline Generic Name: GIGLI SAW INSTRUMENT
• Baseline Model No: NA
• Baseline Catalog No: 656014000
• Baseline ID: NA
• Baseline Device Family: GIGLI SAW INSTRUMENT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-06-27