N4660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-01 for N4660 manufactured by Storz.

Event Text Entries

[4276] Cottle elevator broke at notch during nasal surgery & retained in patient. Retrieved after x-ray. Instrument apparently used properly. No advase effects to patient noted upon follow-up. Device not labeled for single use. Patient medical status prior to event: satisfactory 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8672
• MDR Report Key: 8672
• Date Received: 1994-09-01
• Date of Event: 1994-08-09
• Date Facility Aware: 1994-08-09
• Date Reported to Mfgr: 1994-08-16
• Date Added to Maude: 1994-10-17
• 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

• Generic Name: COTTLE ELEVATOR
• Product Code: KAD
• Date Received: 1994-09-01
• Catalog Number: N4660
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8336
• Manufacturer: STORZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-09-01