Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
- Company
- Northgate Technologies, Inc.
- Recall Initiated
- November 21, 2016
- Terminated
- November 27, 2017
- Recall Number
- Z-0866-2017
- Quantity
- 49 devices
- Firm Location
- Elgin, IL
Reason for Recall
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Distribution
Worldwide Distribution - US including FL and MA. Internationally to Canada
Lot / Code Info
Serial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC
Root Cause
Software design
Action Taken
Northgate Technologies sent an Urgent Medical Device Recall Notification letter dated November 17, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to examine their records and ascertain the location of affected devices, cease distribution or use and quarantine those products appropriately. Ship all affected products in their possession to Northgate Technologies, Inc., 1591 Scottsdale Court, Elgin, IL 60123. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 847-608-9405. If product was further distributed, those customers should be notified immediately. Customers with questions should call 224-856-2253. For questions regarding this recall call 800-348-0424.