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Recall Observatory FDA recall evidence

Device product

Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

Z-0006-2013

November 14, 2011

Class II

Product summary

Firm
US Endoscopy Group Inc
Event
Event 63196
Status
Terminated
Classification
Class II
Quantity
1153
Official record key
device-enforcement:Z-0006-2013

Official wording

Reason: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.

Code information: Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238

Distribution pattern: Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.