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Model Number DGN-538-5 |
Device Problems
Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.Problem code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a rescuenet retrieval net was used during a peroral endoscopy procedure performed on (b)(6) 2022.During the procedure, when the capsule endoscope was grasped outside the body and tried to be inserted into the duodenum with this device, the net in the stomach was detached and the pressure bond part came off and could not be inserted into the duodenum.Four rescuenets were used to remove the residue in the stomach.When the rescuenet loop was removed from the body the net was noticed to be torn.The procedure was completed with a non bsc device.The procedure took 5 hours to complete.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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