BOSTON SCIENTIFIC - MARLBOROUGH INJECTION GOLD PROBE¿; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00560150 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Reported event of the tip detaching.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 an injection gold probe¿ was used during an esophagogastroduodenoscopy (egd) procedure performed in the stomach on (b)(6) 2016.According to the complainant, during the procedure, the ceramic tip of the injection gold probe¿ detached from the distal end of the device.The physician searched the gi tract for the detached tip, however, it was not found.It was reported that the tip may have fallen out of the scope into the operating room.Per the physician's assessments, there were no further bleeds to be treated and the device was removed, thus completing the procedure.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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Visual analysis of the returned injection gold probe¿ found that part of the ceramic distal tip was broken off in the distal section of the device, and the detached broken piece was not returned; however, the proximal end of the ceramic distal tip is attached to the device, which is evidence of that it was attached correctly during the manufacturing process.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record 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 an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed in the stomach on (b)(6) 2016.According to the complainant, during the procedure, the ceramic tip of the injection gold probe detached from the distal end of the device.The physician searched the gi tract for the detached tip, however it was not found.It was reported that the tip may have fallen out of the scope into the operating room.Per the physician's assessments, there were no further bleeds to be treated and the device was removed, thus completing the procedure.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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