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 08/29/2023 |
Event Type
malfunction
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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.
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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 used during an unknown procedure on (b)(6) 2023 when it was reported, ¿cautery pencil stayed on, even when button was not pressed.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned.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 used during an unknown procedure on (b)(6) 23 when it was reported, ¿cautery pencil stayed on, even when button was not pressed.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned.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 device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 15 complaints, regarding 21 devices, for this device family and failure mode.(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,qty20, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿cautery pencil stayed on, even when button was not pressed.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned.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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Update evaluation: received one (b)(4) in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the complaint was confirmed.The coag button activated upon insertion.Upon further investigation a stuck coag button was confirmed within the inside components which could potentially be due to force.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 15 complaints, regarding 21 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
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Search Alerts/Recalls
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