Signature Laparoscopic Dolphin Nose Grasper Instrument Insulation Defect
Silex Medical is recalling 2 units of a Signature Laparoscopic Instruments Dolphin Nose Grasper with Rotating Shaft due to incomplete insulation on the shaft, leaving an exposed area near the rotator wheel.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device with an insulation defect that could potentially cause unintended electrosurgical contact or injury during laparoscopic procedures. No reported injuries are documented in the source text, but the hazard is direct and inherent to the defect.
Plain-English summary
Silex Medical, LLC is recalling the Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number: 5860020) due to a manufacturing defect.
The insulation on the tube does 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. This defect affects 2 units with Lot Number M28181 and Serial Numbers 0691 and 0692.
The affected instruments were distributed nationwide in Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii. Facilities that received this product should stop use and contact Silex Medical, LLC for instructions on returning or replacing the affected units.
The recalled product
- Product
- Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
- Manufacturer
- Silex Medical, LLC
- Hazard
- insulation-defect
- electrosurgical-contact
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 0692.
Distribution
Distributed nationwide across the United States.
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