CONMED CORPORATION AES-90SN PROBE ASSY,SUCT,SIN; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Model Number AES-90SN |
Device Problems
Material Fragmentation (1261); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record have been reviewed and found a ncr however it is not related to the reported event.Additionally, no abnormalities were found that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised to not use the probe for mechanical displacement of tissue, damage to the probe may occur.The ifu also advises the user to maintain the probe tip, including the return electrode, in the field of view at all times.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Care should be taken in procedures that may cover the probe return electrode.Alternate site ablation may occur if 75% of the return electrode is masked, making the return electrode surface area smaller than that of the active electrode.If partial coverage of the return electrode is required for the procedure, use a lower setting and maintain visibility of the return electrode while applying rf.Do not activate the probe while any portion of the active or return electrode is in contact with another metal object, including the scope; localized heating of the electrode and the adjacent metal object may result in product damage and/ or injury.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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On behalf of the customer, conmed (b)(4) received notification of an issue involving the aes-90sn probe, lot # 202012211 that occurred at (b)(6) on (b)(6) 2021.It was reported only that during a shoulder scope procedure, the silver face plate came off while the instrument was being used.It is indicated the procedure was successfully completed using another edgeablator.There was no impact or injury to the patient.Although requested, no clarification was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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