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 10/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device component code (b)(4) relates to device problem code (b)(4) for the reported event of injection gold probe would not conduct energy.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 stomach during an oesophago-gastroduodenoscopy (ogd) procedure performed on (b)(6), 2016.According to the complainant, during the procedure the injection gold probe would not conduct energy.The procedure was completed with another injection 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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Investigation result: a visual evaluation of the returned device presented no visible failures.An electrical load test was performed and the results were found to be within specification.The investigation was unable to confirm the reported event of injection gold probe failed to cauterize.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 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 stomach during an oesophago-gastroduodenoscopy (ogd) procedure performed on (b)(6) 2016.According to the complainant, during the procedure the injection gold probe would not conduct energy.The procedure was completed with another injection 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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