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Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).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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It was reported to boston scientific corporation that a capio¿ slim device was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after deployment of the suture on the right side of the patient, the needle detached and remained in the capio cage.The procedure was completed with the same capio¿ slim device.There were no complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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Analysis of the returned capio¿ slim device revealed that the device does not have any visual failure.The carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot without any issues.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the reported issue was unable to be confirmed.
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Event Description
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It was reported to boston scientific corporation that a capio¿ slim device was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after deployment of the suture on the right side of the patient, the needle detached and remained in the capio cage.The procedure was completed with the same capio¿ slim device.There were no complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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