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Model Number M0068311251 |
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 Date 05/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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 medwatch 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.Refer to manufacturer report #3005099803-2018-01727 for the other associated device information.It was reported to boston scientific corporation that two capio¿ opc devices were used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the first capio device (mfr report #3005099803-2018-01727) sheared the suture and they almost lost the dart inside the patient.Reportedly, they then tested the capio device outside the patient and revealed a misaligned carrier.They opened a second device (mfr report #3005099803-2018-01728) and the same issue occurred.The procedure was completed with another of the same capio¿ opc.There was no apparent harm done to 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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Manufacturer Narrative
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Analysis of the returned capio opc device revealed that it does not have any visual failure.Also, 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) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.The investigation concluded that the device did not present any visual issue and it worked as intended.Returned device review includes visual and functional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore the most probable cause for the complaint is not confirmed returned.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01727 for the other associated device information.It was reported to boston scientific corporation that two capio opc devices were used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the first capio device (mfr report #3005099803-2018-01727) sheared the suture and they almost lost the dart inside the patient.Reportedly, they then tested the capio device outside the patient and revealed a misaligned carrier.They opened a second device (mfr report #3005099803-2018-01728) and the same issue occurred.The procedure was completed with another of the same capio opc.There was no apparent harm done to 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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