PHACO-EMULSIFICATION NEEDLE D8102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-25 for PHACO-EMULSIFICATION NEEDLE D8102 manufactured by Storz.

Event Text Entries

[2450] Foreign body described as "ribbon-like gold metalic", "color of phaco needle", approximately 2-3mm long noted in patient's eye during phaco-emulsification procedure. Surgeon successfully removed the foreign body after approximately 10 minutes of intraoperative time. The surgeon had visually examined the needle under the microscope prior to use. The patient sustained no known permanent injury. Judging from your questionnaire (copy attached), the issue of fragments associated with this equipment is not unknown to you. 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: manufacturing, material degradation/deterioration, none or unknown, none or unknown, unanticipated short term complication of procedure, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. 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: 3518
• MDR Report Key: 3518
• Date Received: 1993-02-25
• Date of Report: 1992-12-30
• Date of Event: 1992-12-01
• Date Facility Aware: 1992-12-01
• Report Date: 1992-12-30
• Date Reported to FDA: 1992-12-30
• Date Reported to Mfgr: 1992-12-02
• Date Added to Maude: 1993-04-21
• 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: PHACO-EMULSIFICATION NEEDLE
• Generic Name: PHACO-EMULSIFICATION NEEDLE
• Product Code: HNM
• Date Received: 1993-02-25
• Model Number: D8102
• Catalog Number: D8102
• Lot Number: NOT KNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-OCT-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3260
• Manufacturer: STORZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-02-25