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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66918
Product Type Devices
Status Ongoing
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing. Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271 M10080721 M10081024 M10090325 M10091113 M10100804 S10080624 710301 802061 910072 M10080722 M10081027 M10090325 M10091120 M10100810 S10080626 710302 802072 1610072 M10080723 M10081028 M10090401 M10091130 M10100813 S10080708 711052 802082 M10080603 M10080724 M10081029 M10090407 M10091209 M10100820 S10080709 711062 802122 M10080603 M10080725 M10081031 M10090415 M10091211 M10100902 S10080711 711072 802131 M10080603 M10080728 M10081104 M10090417 M10091214 M10100924 S10080712 711082 802152 M10080605 M10080729 M10081110 M10090427 M10091216 M10100927 S10080715 711092 802202 M10080606 M10080730 M10081111 M10090505 M10100113 M10100929 S10080718 711122 802212 M10080609 M10080731 M10081112 M10090514 M10100118 M10101026 711142 802252 M10080610 M10080801 M10081117 M10090519 M10100123 M10101103 711152 802262 M10080612 M10080804 M10081119 M10090521 M10100128 M10101118 711262 802272 M10080616 M10080805 M10081120 M10090526 M10100129 M10101123 711282 803042 M10080617 M10080806 M10081124 M10090604 M10100209 M10101124 711302 803101 M10080618 M10080807 M10081125 M10090605 M10100212 M10101209 712042 803112 M10080618 M10080808 M10081127 M10090616 M10100222 M10110113 712062 803132 M10080618 M10080811 M10081128 M10090704 M10100225 M10110131 712102 803172 M10080619 M10080812 M10081201 M10090713 M10100302 M10110208 712112 803192 M10080620 M10080813 M10081204 M10090717 M10100308 M10110210 712142 803212 M10080623 M10080814 M10081205 M10090728 M10100312 M10110217 712182 803241 M10080624 M10080815 M10081209 M10090810 M10100323 M10110224 712192 803261 M10080625 M10080818 M10081210 M10090811 M10100326 M10110304 712212 803271 M10080626 M10080819 M10081211 M10090817 M10100408 M10110310 801021 804081 M10080627 M10080820 M10081218 M10090826 M10100430 M10110317 801072 804101 M10080630 M10080821 M10090107 M10090901 M10100506 M10110323 801092 804121 M10080701 M10080825 M10090112 M10090905 M10100507 M10110419 801142 804171 M10080702 M10080828 M10090115 M10090911 M10100511 M10110506 801152 804221 M10080704 M10080901 M10090127 M10090922 M10100518 M10110523 801171 804231 M10080707 M10080902 M10090127 M10091001 M10100601 S10080603 801212 804241 M10080708 M10080903 M10090128 M10091002 M10100602 S10080606 801222 804261 M10080709 M10080904 M10090203 M10091015 M10100607 S10080606 801242 804291 M10080710 M10080905 M10090205 M10091027 M10100625 S10080612 801252 805071 M10080711 M10080909 M10090209 M10091102 M10100722 S10080612; Part number 420006 used on IS2000: lot numbers: 610072 801252 804221 M10080624 M10080815 M10081020 M10081219 M10090501 M10090813 M10091209 S10080702 710222 801282 804231 M10080624 M10080818 M10081021 M10081222 M10090504 M10090814 M10091210 S10080705 710242 801302 804241 M10080624 M10080819 M10081022 M10081223 M10090509 M10090820 M10091211 S10080705 711052 802042 804291 M10080625 M10080820 M10081023 M10090105 M10090511 M10090821 M10091212 S10080707 711062 802052 805051 M10080626 M10080821 M10081024 M10090106 M10090513 M10090831 M10091215 S10080710 711072 802072 805091 M10080703 M10080822 M10081028 M10090109 M10090514 M10090901 M10091217 S10080714 711082 802082 805121 M10080704 M10080825 M10081029 M10090116 M10090519 M10090905 M10091218 S10080715 711092 802131 805171 M10080707 M10080827 M10081030 M10090119 M10090520 M10090907 M10091221 S10080717 711122 802142 805201 M10080708 M10080828 M10081031 M10090122 M10090521 M10090909 M10100104 S10081120 711128 802152 805231 M10080709 M10080901 M10081103 M10090123 M10090526 M10090910 M10100105 711132 802202 805241 M10080710 M10080902 M10081107 M10090126 M10090529 M10090916 M10100112 711142 802212 805291 M10080711 M10080903 M10081110 M10090129 M10090603 M10090921 M10100115 711152 802252 805311 M10080716 M10080904 M10081111 M10090130 M10090605 M10090924 M10100119 711272 802262 1110072 M10080718 M10080908 M10081112 M10090204 M10090611 M10090929 M10100122 711282 802272 1710072 M10080721 M10080909 M10081114 M10090206 M10090612 M10091005 M10100126 711302 803041 M10080603 M10080721 M10080910 M10081118 M10090213 M10090615 M10091010 M10100129 712042 803062 M10080605 M10080722 M10080911 M10081119 M10090220 M10090617 M10091012 M10100203 712062 803101 M10080606 M10080723 M10080919 M10081120 M10090223 M10090625 M10091019 M10100204 712102 803112 M10080609 M10080723 M10080922 M10081124 M10090224 M10090703 M10091022 M10100205 712122 803132 M10080610 M10080724 M10080923 M10081125 M10090225 M10090710 M10091026 M10100208 712142 803172 M10080612 M10080725 M10080924 M10081127 M10090226 M10090711 M10091029 M10100211 712182 803192 M10080616 M10080728 M10080925 M10081128 M10090303 M10090715 M10091102 M10100216 712192 803212 M10080617 M10080729 M10080926 M10081201 M10090304 M10090716 M10091105 M10100217 712212 803241 M10080618 M10080730 M10080929 M10081202 M10090305 M10090717 M10091111 M11090226 712262 803261 M10080618 M10080731 M10080930 M10081203 M10090309 M10090718 M10091117 MI0080605 712272 803271 M10080618 M10080801 M10081001 M10081205 M10090310 M10090720 M10091118 MI0080605 801022 803281 M10080619 M10080804 M10081002 M10081208 M10090311 M10090728 M10091119 MI0080605 801072 804031 M10080619 M10080805 M10081003 M10081209 M10090327 M10090729 M10091125 S10080618 801092 804081 M10080619 M10080806 M10081008 M10081210 M10090406 M10090730 M10091126 S10080620 801141 804101 M10080620 M10080807 M10081009 M10081211 M10090414 M10090731 M10091127 S10080624 801152 804141 M10080620 M10080808 M10081010 M10081212 M10090417 M10090803 M10091201 S10080626 801172 804151 M10080620 M10080811 M10081013 M10081215 M10090421 M10090804 M10091202 S10080627 801212 804161 M10080623 M10080812 M10081015 M10081216 M10090424 M10090805 M10091204 S10080628 801222 804181 M10080623 M10080813 M10081016 M10081217 M10090427 M10090806 M10091207 S10080629 801242 804191 M10080623 M10080814 M10081017 M10081218 M10090429 M10090812 M10091208 S10080630 M10100219 M10100514 M10100730 M10101015 M10101217 M10110318 M10110526 M10100222 M10100517 M10100802 M10101019 M10110104 M10110322 M11100303 M10100223 M10100518 M10100805 M10101020 M10110111 M10110323 M11100416 M10100224 M10100520 M10100806 M10101022 M10110117 M10110324 M11100419 M10100225 M10100524 M10100809 M10101025 M10110121 M10110325 M11100420 M10100301 M10100525 M10100811 M10101026 M10110124 M10110328 M11100514 M10100303 M10100526 M10100812 M10101027 M10110125 M10110329 M11100517 M10100304 M10100528 M10100818 M10101028 M10110127 M10110330 M11100621 M10100310 M10100531 M10100819 M10101101 M10110128 M10110331 M11100623 M10100311 M10100601 M10100823 M10101105 M10110201 M10110401 M11100624 M10100312 M10100603 M10100824 M10101108 M10110202 M10110404 M11100719 M10100315 M10100607 M10100826 M10101110 M10110204 M10110406 M11100823 M10100318 M10100608 M10100903 M10101111 M10110208 M10110407 M11100910 M10100322 M10100609 M10100907 M10101112 M10110209 M10110411 M11100930 M10100325 M10100617 M10100910 M10101115 M10110210 M10110412 M11101004 M10100331 M10100618 M10100913 M10101116 M10110211 M10110414 M11101022 M10100405 M10100621 M10100914 M10101118 M10110215 M10110418 M11101025 M10100408 M10100622 M10100915 M10101123 M10110216 M10110419 M11101204 M10100409 M10100623 M10100916 M10101124 M10110221 M10110420 M11101207 M10100412 M10100624 M10100920 M10101125 M10110223 M10110425 M11110119 M10100413 M10100625 M10100921 M10101126 M10110224 M10110427 M11110204 M10100414 M10100705 M10100922 M10101127 M10110225 M10110429 M11110223 M10100415 M10100706 M10100923 M10101129 M10110228 M10110502 M11110310 M10100416 M10100707 M10100924 M10101201 M10110301 M10110503 M11110408 M10100419 M10100708 M10100927 M10101202 M10110302 M10110504 M11110420 M10100420 M10100715 M10100928 M10101204 M10110307 M10110510 M11110510 M10100423 M10100719 M10100930 M10101206 M10110308 M10110513 M12100623 M10100426 M10100720 M10101004 M10101207 M10110309 M10110516 M12100624 M10100427 M10100721 M10101006 M10101210 M10110310 M10110517 M12110420 M10100505 M10100722 M10101007 M10101213 M10110311 M10110519 M10100507 M10100723 M10101011 M10101214 M10110315 M10110520 M10100511 M10100726 M10101012 M10101215 M10110316 M10110524 M10100512 M10100727 M10101014 M10101216 M10110317 M10110525. Class II Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. 94, 981 UPDATED 12/19/13 to 56, 469 Z-0521-2014
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing. Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728 801301 M10110810 803171 M10110816 804121 M10110831 805091 M10110909 805271 M10110920 M10090320 S10080609 M10090512 S10080621 M10090709 S10080729 M10090731 S10080812 M10090812 S10080822 M10090824 S10080910 M10090909 S10080918 M10091020 S10081010 M10091110 S10081029 M10091130 S10081106 M10091211 S10081114 M10100114 S10081201 M10100216 S10081215 M10100218 S10090106 M10100428 S10090210 M10100526 S10090303 M10101026 S10090318 M10101103 S10090320 M10101125 S10090410 S10090715 S10110308. Part number 420194 - used on IS2000: lot numbers: 510071 M10090629 S10080802 710191 M10090706 S10080818 710261 M10090724 S10080822 711061 M10090727 S10080902 711121 M10090731 S10080910 711151 M10090810 S10080917 711191 M10090825 S10080926 712051 M10090828 S10080930 712131 M10090909 S10081002 712262 M10090916 S10081009 801021 M10091005 S10081014 801151 M10091008 S10081016 801181 M10091012 S10081029 801241 M10091030 S10081106 801301 M10091105 S10081114 802121 M10091123 S10081119 802201 M10091124 S10081202 802251 M10091130 S10081209 803121 M10091204 S10081218 803211 M10091211 S10081229 803261 M10091217 S10090106 804031 M10100105 S10090112 804111 M10100112 S10090114 804221 M10100114 S10090119 805121 M10100120 S10090121 805271 M10100122 S10090227 805301 M10100208 S10090302 M10090316 M10100216 S10090305 M10090324 S10080609 S10090312 M10090423 S10080618 S10090316 M10090505 S10080625 S10090318 M10090512 S10080708 S10090320 M10090528 S10080714 S10090327 M10090609 S10080723 S10090402 M10090624 S10080729 S10090406 M10100218 M10110112 M10110726 M10100224 M10110117 M10110802 M10100311 M10110131 M10110805 M10100318 M10110202 M10110809 M10100407 M10110208 M10110811 M10100412 M10110210 M10110817 M10100415 M10110218 M10110825 M10100429 M10110301 M10110901 M10100519 M10110302 M10110906 M10100526 M10110321 M10110913 M10100527 M10110323 M10110920 M10100531 M10110328 M10110923 M10100603 M10110330 S10110307 M10100615 M10110401 M10100713 M10110412 M10100714 M10110419 M10100722 M10110429 M10100723 M10110503 M10100802 M10110511 M10100809 M10110512 M10101001 M10110523 M10101008 M10110527 M10101019 M10110602 M10101026 M10110609 M10101029 M10110614 M10101104 M10110616 M10101109 M10110620 M10101115 M10110622 M10101117 M10110624 M10101122 M10110627 M10101127 M10110701 M10101206 M10110706 M10101215 M10110707 M10101217 M10110714 M10110107 M10110720 Class II Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. 15, 236 UPDATED 12/19/13 to 11,235 Z-0520-2014
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