ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X, G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z, G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711, G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N, G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00, G4TT3F, G4TU3P &G4TX0T. Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4
Recall
- Recall Number
- Z-0336-2011
- Event Number
- 56939
- Firm
- Ethicon Endo-Surgery Inc
- FEI Number
- 1527736
- Product Code
- DRC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 27, 2010
- Terminated
- January 25, 2012
- Address
- 4545 Creek Rd, Cincinnati, OH, 45242-2803
Description
ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X, G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z, G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711, G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N, G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00, G4TT3F, G4TU3P &G4TX0T. Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4
This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. Pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.
Ethicon Endo-Surgery sent an URGENT: DEVICE RECALL EVENT 2244 letter, dated October 8, 2010. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to stop using the product, examine all inventory to determine if they had the affected product on hand, and remove the affected products from inventory. Ethicon Endo-Surgery requested that each customer complete the Business Reply Form and fax it back to Stericycle at (877) 272-6141 with in 3 business days and also return any affected product to Stericycle. For question regarding this recall call (877) 598-5706 and reference 2244.
Worldwide distribution: USA, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, DOMINICAN REPUBLIC,ECUADOR, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, NETHERLANDS ANTILLES, NICARAGUA, PANAMA SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA SPAIN, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES URUGUAY, and VENEZUELA.
671 lots totalling 2,479,134 instruments