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Recall Observatory FDA recall evidence

Device product

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT

Z-1887-2018

March 26, 2018

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 79801
Status
Terminated
Classification
Class II
Quantity
1500
Official record key
device-enforcement:Z-1887-2018

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 P4TD1E R4001U R4052P

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.