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Recall Observatory FDA recall evidence

Device product

5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST

Z-1889-2018

March 26, 2018

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 79801
Status
Terminated
Classification
Class II
Quantity
11074
Official record key
device-enforcement:Z-1889-2018

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 P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642

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.