STRAIGHT COLD KNIFE G5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-17 for STRAIGHT COLD KNIFE G5000 manufactured by Circon.

Event Text Entries

[17805649] Our operating room has experienced problems with the cold knife breaking during use. This knife is used to correct uretheral strictures. Each time the knife was inside the pt when it broke. There have been 3 incidents where the knife fragment was removed, however, a recent incident occurred where the surgeon and his team were unable to remove the knife fragment. The product is no longer being used. Device labeled for single use. Patient medical status prior to event: invalid data. There was multiple patient involvement. Number of patients involved: 3. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: user facility biomedical/bioengineering department. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 21557
• MDR Report Key: 21557
• Date Received: 1995-04-17
• Date of Report: 1995-04-13
• Report Date: 1995-04-13
• Date Reported to FDA: 1995-04-13
• Date Added to Maude: 1995-04-25
• 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: 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: STRAIGHT COLD KNIFE
• Generic Name: STRAIGHT COLD KNIFE
• Product Code: EMF
• Date Received: 1995-04-17
• Model Number: G5000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 21599
• Manufacturer: CIRCON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-04-17