MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number PLP2520 |
Device Problem
Self-Activation or Keying (1557)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Event Description
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The sales representative reported on behalf of the customer that the device, plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20, was being used during a laminectomy procedure on (b)(6) 2024 when it was reported, ¿staff in room heard a high-pitched noise.While investigating they noticed that the cautery pencil was on.They checked to make sure nothing was pressing on the button.It was determined that nothing was pressing on the button.Staff immediately removed the cautery from the field.".There was no report of medical intervention or hospitalization for the patient.The procedure was completed as planned without report of delay.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 is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
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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.A 2 year lot history review shows a total of (b)(4) devices for this lot number and failure mode however, only 1 device is confirmed.A two-year review of complaint history revealed there has been a total of 75 complaints, regarding (b)(4) 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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Event Description
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The sales representative reported on behalf of the customer that the device, plp2520, plume pen elite surgical smoke evac pencil, 15ft tubing,qty 20, was being used during a laminectomy procedure on (b)(6) 2024 when it was reported, ¿staff in room heard a high-pitched noise.While investigating they noticed that the cautery pencil was on.They checked to make sure nothing was pressing on the button.It was determined that nothing was pressing on the button.Staff immediately removed the cautery from the field.".There was no report of medical intervention or hospitalization for the patient.The procedure was completed as planned without report of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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