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 03/01/2024 |
Event Type
malfunction
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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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Event Description
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The customer reported that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty (b)(4) was being used on 1mar24 during a laminectomy and the ¿staff in room heard high pitch noise.After investigating it was noted that the cautery pencil was activated while in holster.Pencil removed from field.¿.There was no impact or injury to the patient.The procedure was completed with a 2 minute delay.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 customer reported that the plp2520, plumepen elite surgical smoke evac pencil, 15ft tubing,qty20 was being used on (b)(6) 2024 during a laminectomy and the ¿staff in room heard high pitch noise.After investigating it was noted that the cautery pencil was activated while in holster.Pencil removed from field.¿.There was no impact or injury to the patient.The procedure was completed with a 2 minute 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 will not be returned and no photographic evidence was provided therefore, a device malfunction cannot be verified.A 2 year lot history review shows a total of 2 devices for this lot number and failure mode.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.(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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