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Recall Observatory FDA recall evidence

Device product

5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT

Z-1888-2018

March 26, 2018

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 79801
Status
Terminated
Classification
Class II
Quantity
95233
Official record key
device-enforcement:Z-1888-2018

Official wording

Reason: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.

Code information: Lots P4T636 P4T63G P4T689 P4T708 P4T86Z P4T882 P4T89N P4T97L P4T994 P4TA0T P4TA17 P4TA55 P4TA70 P4TA7R P4TC53 P4TC7X P4TC87 P4TC8U P4TC93 P4TD1Y R4003L R40048 R4005Z R4010L R4012F R40142 R4020P R4021H R4027N R4042X R4045N R4046X R4054H

Distribution pattern: Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.