BOSTON SCIENTIFIC CORPORATION JAGTOME REVOLUTION RX; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00584240 |
Device Problems
Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a jagtome revolution rx was unpacked for an unknown procedure performed on (b)(6) 2021.During unpacking, it was noticed that the back of the packaging was sliced and the device was deemed unsterile.Note: a photo of the complaint device was provided by the complainant and shows a cut in the sterile pouch.
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Search Alerts/Recalls
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