BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505000 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 an obtryx system - halo device was used during a sui sling, tot procedure performed on (b)(6) 2022 for the treatment of stress urinary incontinence.During the procedure, it was reported that piece of the sling broke off inside the patient and was retrieved by a hand tool.The procedure was completed with another obtryx system - halo device.There were no patient complications reported as a result of the event.
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Search Alerts/Recalls
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