MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number D2201 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/19/2020 |
Event Type
Injury
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Event Description
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It was reported that during a water vapor thermal therapy procedure the patient was administered a prostate block and the needle did not retract back.The safety pin was pulled, however the needle remained deployed.The physician confirmed that hematuria symptom was not present at the time of the procedure.The cause of the bleeding was attributed to the needle not retracting back.The doctor performed a manual retraction of the delivery device and the needle still did not retract.The needle had to be narrowly deployed to be removed and the procedure was aborted.The patient was released from the hospital with a catheter and will be monitored for continuous bleeding.The patient had a follow-up appointment with the physician 5 days post procedure, and it was noted that the bleeding stopped, and the catheter was taken off per the discretion of the physician.The patient is in good health.
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Manufacturer Narrative
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The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.A review of the labeling did not identify any evidence of device misuse, off-label use or failure to follow instructions.The device was returned with the shaft and needle removed, the needle was within the shaft.The needle was bent in several places, this is a typical observation if the device had been manually retracted as the needle is outside the shaft.In this case the needle was received within the shaft.The needle was inspected under microscopy and no evidence of defects were found.A new needle was used to reassemble the device and it was connected to a generator for functional testing.There were no issues with needle deployment or retraction and the buttons on the returned device functioned as intended.The device was checked for electrical shorts and open circuits on the printed circuit board (pcb) via the generator servicing screen, no issues were found.The manual retraction method was tested with the device and completed without issue.The most likely cause of the bent needle is drift during the procedure or from the scope used in the procedure blocking the needle.The damage to the needle is unrelated to the reported event.The reported hemorrhage is a known inherent risk of the device.Based on the returned device investigation results, an evaluation conclusion code of no problem detected was assigned to the event as there was no defect found on the device that is related to the reported device issue or patient complication.
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Event Description
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It was reported that during a water vapor thermal therapy procedure the patient was administered a prostate block and the needle did not retract back.The safety pin was pulled, however the needle remained deployed.The physician confirmed that hematuria symptom was not present at the time of the procedure.The cause of the bleeding was attributed to the needle not retracting back.The doctor performed a manual retraction of the delivery device and the needle still did not retract.The needle had to be narrowly deployed to be removed and the procedure was aborted.The patient was released from the hospital with a catheter and will be monitored for continuous bleeding.The patient had a follow-up appointment with the physician 5 days post procedure, and it was noted that the bleeding stopped, and the catheter was taken off per the discretion of the physician.The patient is in good health.
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