BOSTON SCIENTIFIC - SPENCER UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device component code is related to device problem code for the problem of needle detachment.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2018-00364 pertains to the other device it was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the needle (¿the olive which had to be inserted in the ancillary¿) detached and was not retrieved from the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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