Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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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This report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03268 pertains to the other device.It was reported to boston scientific corporation that a capio¿ slim device was used during a hysterectomy procedure performed on an unknown date.According to the complainant, during the procedure, the needle detached from the suture.The detached piece was found in the capio cage (ancillary reservoir).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 device revealed that the carrier was able to extend and retract without issues, however, the cage was bent and this condition could contribute to the reported failure "needle detached." 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.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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This report pertains to one of two devices used during the same procedure.Associated mfr report #3005099803-2017-03268 pertains to the other device.It was reported to boston scientific corporation that a capio¿ slim device was used during a hysterectomy procedure performed on an unknown date.According to the complainant, during the procedure, the needle detached from the suture.The detached piece was found in the capio cage (ancillary reservoir).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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