MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number PLP2020 |
Device Problem
Device Remains Activated (1525)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2023 |
Event Type
malfunction
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Event Description
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The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being pre-operatively tested prior to an unknown procedure on (b)(6) 2023 when it was reported, ¿when the cautery is first turned on at the pencil, it stays on and will not turn off when the button is released.In order to turn off the cautery it had to be removed from the electrosurgical generator.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned using an alternate, unknown device.There was no report of delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
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Manufacturer Narrative
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The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty (b)(4), was being pre-operatively tested prior to an unknown procedure on (b)(6) 2023 when it was reported, "when the cautery is first turned on at the pencil, it stays on and will not turn off when the button is released.In order to turn off the cautery it had to be removed from the electrosurgical generator." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned using an alternate, unknown device.There was no report of delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Event Description
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The sales representative reported on behalf of the customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20, was being pre-operatively tested prior to an unknown procedure on (b)(6) 2023 when it was reported, ¿when the cautery is first turned on at the pencil, it stays on and will not turn off when the button is released.In order to turn off the cautery it had to be removed from the electrosurgical generator.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned using an alternate, unknown device.There was no report of delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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Follow up evaluation: received two plp2020 in opened original packaging.Lot number was verified.Performed a visual inspection, the coag button is concaved within the handpiece causing constant connection with the circuit board.Performed a functional inspection using the esu system 7550 (c8406), the devices continuously activate.A determination for further investigation has been initiated.Previous evaluation: the device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 42 complaints, regarding 51 devices, for this device family and failure mode.During this same time frame 4,112,140 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00001.We will continue to monitor for trends through the complaint system to assure patient safety.
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