Model Number M00560150 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/12/2017 |
Event Type
malfunction
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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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an injection gold probe¿ was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure the device failed to cauterized.The procedure was completed with another injection gold probe¿.There were no patient complications reported as a result of this event.There were no patient harm at the conclusion of the procedure.
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Manufacturer Narrative
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Investigation results: a visual evaluation of the returned device found no visible failures.An electrical load test was performed and the device tested to be within specification.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.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. a search of the complaint database confirmed that no other complaints exist for the specified batch.
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Event Description
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It was reported to boston scientific corporation that an injection gold probe¿ was used in the duodenum during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure the device failed to cauterized.The procedure was completed with another injection gold probe¿.There were no patient complications reported as a result of this event.There were no patient harm at the conclusion of the procedure.
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Search Alerts/Recalls
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