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U.S. Department of Health and Human Services

Class 2 Device Recall 8MM,MONOPOLAR CURVED SCISSORS

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 Class 2 Device Recall 8MM,MONOPOLAR CURVED SCISSORSsee related information
Date Initiated by FirmDecember 19, 2024
Date PostedJanuary 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0847-2025
Recall Event ID 95938
510(K)NumberK131861 K220023 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Code Information Model Number: 470179 Part Number: 470179-19 UDI-DI code: 00886874112298 Batch Number: K10221127 K10221218 K10221228 K10230103 K10230108 K10230112 K10230122 K10230129 K10230205 K10230212 K10230219 K10230226 K10230302 K10230310 K10230315 K10230316 K10230323 K10230330 K10230403 K10230405 K10230412 K10230413 K10230420 K10230504 K10230509 K10230511 K10230516 K10230518 K10230525 K10230531 K10230601 K10230602 K10230608 K10230615 K10230620 K10230622 K10230629 K10230630 K10230706 K10230713 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10230928 K10231005 K10231006 K10231012 K10231019 K10231026 K10231102 K10231109 K10231123 K10231130 K10231207 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240125 K10240201 K10240208 K10240215 K10240222 K10240229 K10240301 K10240307 K10240314 K10240315 K10240321 K10240327 K10240410 K10240411 K10240418 K10240425 K10240426 K10240502 K10240515 K10240516 K10240523 K10240530 K10240605 K10240606 K10240613 K10240620 K10240627 K10240702 K10240713 K11221127 K11221128 K11221218 K11230103 K11230108 K11230112 K11230122 K11230129 K11230205 K11230212 K11230219 K11230226 K11230302 K11230310 K11230315 K11230316 K11230323 K11230330 K11230403 K11230405 K11230412 K11230413 K11230420 K11230504 K11230509 K11230511 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230629 K11230630 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231005 K11231006 K11231012 K11231019 K11231026 K11231102 K11231109 K11231123 K11231130 K11231207 K11231214 K11231218 K11240104 K11240111 K11240118 K11240125 K11240201 K11240208 K11240215 K11240222 K11240229 K11240307 K11240314 K11240321 K11240327 K11240404 K11240411 K11240418 K11240425 K11240502 K11240509 K11240515 K11240516 K11240523 K11240530 K11240605 K11240606 K11240613 K11240620 K11240627 K11240702 K12221128 K12221212 K12221218 K12230103 K12230108 K12230112 K12230122 K12230129 K12230205 K12230212 K12230219 K12230226 K12230302 K12230310 K12230316 K12230323 K12230330 K12230405 K12230412 K12230413 K12230420 K12230504 K12230509 K12230511 K12230518 K12230525 K12230601 K12230608 K12230615 K12230622 K12230629 K12230706 K12230713 K12230727 K12230803 K12230810 K12230817 K12230824 K12230831 K12230907 K12230914 K12230921 K12230928 K12231005 K12231006 K12231012 K12231019 K12231026 K12231109 K12231123 K12231130 K12231207 K12231214 K12231218 K12240104 K12240111 K12240118 K12240125 K12240201 K12240208 K12240215 K12240222 K12240229 K12240307 K12240321 K12240327 K12240404 K12240411 K12240418 K12240425 K12240502 K12240509 K12240516 K12240523 K12240530 K12240606 K12240613 K12240620 K12240627 K12240702 K13221128 K13230103 K13230108 K13230112 K13230122 K13230129 K13230205 K13230212 K13230219 K13230226 K13230302 K13230316 K13230323 K13230330 K13230405 K13230413 K13230420 K13230504 K13230511 K13230518 K13230525 K13230601 K13230608 K13230615 K13230622 K13230706 K13230713 K13230727 K13230803 K13230810 K13230817 K13230824 K13230831 K13230907 K13230914 K13230921 K13230928 K13231005 K13231012 K13231019 K13231026 K13231109 K13231123 K13231130 K13231207 K13231214 K13231218 K13240104 K13240118 K13240125 K13240201 K13240208 K13240215 K13240222 K13240229 K13240307 K13240321 K13240327 K13240404 K13240411 K13240418 K13240425 K13240502 K13240509 K13240516 K13240523 K13240530 K13240606 K13240613 K13240627 K13240702 K14221128 K14221212 K14221218 K14230103 K14230108 K14230112 K14230122 K14230129 K14230212 K14230226 K14230323 K14230413 K14230420 K14230504 K14230511 K14230518 K14230525 K14230601 K14230608 K14230615 K14230622 K14230706 K14230727 K14230803 K14230810 K14230817 K14230824 K14230831 K14230914 K14230921 K14230928 K14231005 K14231012 K14231026 K14231109 K14231123 K14231130 K14231207 K14231214 K14231218 K14240104 K14240111 K14240118 K14240125 K14240201 K14240208 K14240215 K14240222 K14240229 K14240307 K14240314 K14240321 K14240327 K14240404 K14240411 K14240425 K14240502 K14240509 K14240516 K14240523 K14240530 K14240606 K14240613 K14240620 K14240627 K14240702 K15221128 K15221212 K15221218 K15230108 K15230112 K15230122 K15230129 K15230212 K15230226 K15230323 K15230405 K15230413 K15230420 K15230427 K15230518 K15230525 K15230727 K15230810 K15230824 K15230921 K15231005 K15231012 K15231116 K15231123 K15231207 K15231214 K15231218 K15240104 K15240118 K15240125 K15240208 K15240215 K15240222 K15240229 K15240307 K15240314 K15240404 K15240411 K15240502 K15240509 K15240516 K15240523 K15240530 K15240606 K15240613 K15240620 K15240627 K15240702 K16221212 K16221218 K16230122 K16230212 K16230427 K16230525 K16230810 K16231005 K16231012 K16231116 K16231123 K16231207 K16231214 K16240104 K16240118 K16240208 K16240215 K16240222 K16240229 K16240307 K16240404 K16240411 K16240502 K16240509 K16240516 K16240523 K16240530 K16240606 K16240613 K16240620 K16240627 K16240702 K17221218 K17230122 K17230427 K17231116 K17240104 K17240229 K17240307 K17240411 K17240502 K17240523 K17240613 K18221212 K18221218 K18230427 K18231116 K18240229 K18240307 K18240411 K18240502 K19221212 K19221218 K19230427 K19231116 K19240229 K19240307 Part Number: 470179-21 UDI-DI code: 00886874112298 Batch Number: K10240509 K10240607 K10240718 K10240719 K10240725 K10240801 K10240805 K10240808 K10240822 K10240826 K10240829 K11240711 K11240718 K11240725 K11240801 K11240808 K11240815 K12240711 K12240718 K12240725 K12240801 K12240815 K13240711 K13240718 K13240725 K13240801 K14240711 K14240718 K14240725 K14240801 K15240711 K15240718 K15240801 K16240711 K16240808 K16240829 K17240808 Part Number: 470179-22 UDI-DI code: 00886874112298 Batch Number: K10230914 K10240229 K11230803
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
408-523-2443
Manufacturer Reason
for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA Determined
Cause 2
Process change control
ActionOn 12/19/2024, the firm send via email an "Urgent: Medical Device Correction" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments. Customer are instructed to: 1. Customers can continue using the products in accordance with the user manual. 2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. In addition, please refer to Appendix B for additional images for detection of grip cable failures. 3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process. 4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process. For Question and assistance - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
Quantity in Commerce355,547
DistributionU.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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