FDA-Device2025-06-11Class II
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Silex Medical, LLC
Hazard
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Sold states
US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Affected count
8 units
Manufactured in
24 Robert Porter Rd Ste B, N/A, Southington, CT, United States
Products
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1895-2025Don't want to check this manually?
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