NABATOFF VEIN STRIPPER SU11770

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-06-06 for NABATOFF VEIN STRIPPER SU11770 manufactured by Allegiance Healthcare - Distribution.

Event Text Entries

[16396838] During vein stripping/ligation, the vein stripper malfunctioned due to "stripped threads on the wire causing the screw-on tip to be liberated in the left greater saphenous vein. Surgeon able to remove it through an additional incision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000008-2001-00006
• MDR Report Key: 336210
• Report Source: 05,06
• Date Received: 2001-06-06
• Date of Report: 2001-06-06
• Date of Event: 2001-01-22
• Date Facility Aware: 2001-05-07
• Date Reported to FDA: 2001-06-06
• Date Reported to Mfgr: 2001-05-15
• Date Added to Maude: 2001-06-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NABATOFF VEIN STRIPPER
• Generic Name: INSTRUMENT
• Product Code: GAI
• Date Received: 2001-06-06
• Returned To Mfg: 2001-05-15
• Model Number: SU11770
• Catalog Number: SU11770
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 325521
• Manufacturer: ALLEGIANCE HEALTHCARE - DISTRIBUTION
• Manufacturer Address: 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US
• Baseline Brand Name: NABATOFF VEIN STRIPPER
• Baseline Generic Name: INSTRUMENT
• Baseline Model No: SU11770
• Baseline Catalog No: SU11770
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2001-06-06