SERIES TEN THOUSAND UNI PAK SURGICAL SUPPLIES-CAVITRON/ 10530F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for SERIES TEN THOUSAND UNI PAK SURGICAL SUPPLIES-CAVITRON/ 10530F manufactured by Alcorn Surgical, Inc..

Event Text Entries

[18142555] The surgeon was performing a cataract extraction and, during the procedure, noticed a foreign body in the anterior chamber of the eye. This appeared to have come from the port of the phaco handpiece. The specimen was retrieved from the eye and sent to pathology for examination. The involved patient suffered no ill effects and was discharged. The pathology report for the foreign body identified that it was probably a plastic type material. Device 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: visual examination, other. Results of evaluation: foreign material contamination. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3379
• MDR Report Key: 3379
• Date Received: 1992-07-23
• Date of Report: 1992-06-11
• Date of Event: 1992-06-03
• Date Facility Aware: 1992-06-03
• Report Date: 1992-06-11
• Date Reported to Mfgr: 1992-06-11
• Date Added to Maude: 1993-04-16
• 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: SERIES TEN THOUSAND UNI PAK SURGICAL SUPPLIES-CAVITRON/
• Generic Name: KELMAN PHACO-EMULSIFIER ASPIRATOR
• Product Code: HOY
• Date Received: 1992-07-23
• Catalog Number: 10530F
• Lot Number: 92059
• Device Expiration Date: 1997-02-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3151
• Manufacturer: ALCORN SURGICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-23