Model Number M00521232 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2020 |
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 a resolution 360 clip device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip would not deploy.The procedure was successfully completed with an unknown device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a resolution 360 clip device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip would not deploy.The procedure was successfully completed with an unknown device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6), 2020*** it was reported that three resolution 360 clip devices were used in the lower esophagus during this procedure.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: device code 2906 captures the reportable event of clip would not deploy.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: according to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (describe event or problem), d8 (sud reprocessed and reused), h6 (patient code) h8 (usage of device), h10 (additional mfr narrative).
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Search Alerts/Recalls
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