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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 05/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon 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 three devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01902 and 3005099803-2018-01900 for the other associated device information.It was reported to boston scientific corporation that three capio¿ slim devices were used during an anterior and posterior repair with biologic graft procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the carrier of the first two devices broke off.The carrier of the first device [mfr report #3005099803-2018-01899] broke in half, and the second one [mfr report #3005099803-2018-01902] broke off completely.The broken carriers were removed from the patient with the use of pickup forceps.For the third device used [mfr report #3005099803-2018-01900], the capio carrier and cage mechanism was reportedly stuck and would not retract.The procedure was completed with a different device.There were no patient complications reported as a result of these events.The patient's condition at the conclusion of the procedure was reported to be fine.
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Manufacturer Narrative
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A visual examination of the returned capio slim revealed that the carrier was broken.The broken section of the carrier was not returned by the customer.A functional examination of the device was not performed due to the device condition (carrier broken).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.However, the investigation concluded that the root cause for this complaint is design product enhancement since a modification would improve performance, function or appearance of the product.Furthermore, a labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.There is an investigation open to address the issue of "carrier broken.".
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Event Description
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Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01902 and 3005099803-2018-01900 for the other associated device information.It was reported to boston scientific corporation that three capio slim devices were used during an anterior and posterior repair with biologic graft procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the carrier of the first two devices broke off.The carrier of the first device [mfr report #3005099803-2018-01899] broke in half, and the second one [mfr report #3005099803-2018-01902] broke off completely.The broken carriers were removed from the patient with the use of pickup forceps.For the third device used [mfr report #3005099803-2018-01900], the capio carrier and cage mechanism was reportedly stuck and would not retract.The procedure was completed with a different device.There were no patient complications reported as a result of these events.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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