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 10/28/2016 |
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)2016.According to the complainant, during 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 fine.
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Manufacturer Narrative
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Investigation results: a visual evaluation of the returned gold probe noted that the catheter was kinked in the middle of the device.An electrical load test was performed and the results was found to be within specification.The condition of the returned device was not consistent with the complaint that the device failed to transmit current; the complaint was not confirmed.The returned device showed neither evidence of the alleged issue nor 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) 2016.According to the complainant, during 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 fine.
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Search Alerts/Recalls
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