SAME N/A 401-1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-04 for SAME N/A 401-1500 manufactured by Site Microsurgical Systems, Inc..

Event Text Entries

[653] It was reported to me that a vitrious leak occurred during surgery. The site-unit was in use and the guillotine tip was set up but would not turn sufficiently. Rep was present, and whether the tip or the footpedal was a problem was not determined. Subsequent inspection and testing after the case demonstrated no problem with either. Tip sent to iolab for evaluation. The handpiece was not found to be problematic. Inspection by another rep, before the tip was sent out also indicated that the tip worked but operation could be smoother. After review, iolab suggested repair or dreplacement. Patient required second surgerydevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: distributor. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: performance tests performed, visual examination. Results of evaluation: component failure. Conclusion: intermittent failure directly contributed to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device discarded. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1076
• MDR Report Key: 1076
• Date Received: 1992-07-04
• Date of Event: 1992-06-02
• Date Facility Aware: 1992-06-02
• Date Reported to Mfgr: 1992-06-03
• Date Added to Maude: 1992-08-18
• 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: SAME
• Generic Name: GUILLOTINE TIP
• Product Code: KBO
• Date Received: 1992-07-04
• Model Number: N/A
• Catalog Number: 401-1500
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1032
• Manufacturer: SITE MICROSURGICAL SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-04