Model Number M00560071 |
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 07/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the gold probe failed to cauterize.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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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) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
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Event Description
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It was reported to boston scientific corporation that a gold probe was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the gold probe failed to cauterize.The procedure was completed with another gold probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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