Model Number 8360-10 |
Device Problem
Arcing (2583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report, if applicable.
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Event Description
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It was reported that there was an issue a with prestige grasper(s).During insulation testing in sterile processing department it was noticed the product was failing and causing an arc.Per the submission, this incident did not occur in surgery.Additional information has been requested to clarify that the arcing did not cause injury, and exactly how many instruments were involved.
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Manufacturer Narrative
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The supplier, (b)(4) has been notified and is aware that the instrument may have been damaged during testing.The customer facility was re-instructed on guidelines for use and processing of the device.
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Event Description
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Clarification was received : it was confirmed that electrical testing had been performed, although the instructions for use (ifu) specifically state otherwise: ""the prestige endoscopic instruments are not electrical instruments.Do not perform electrical testing on the instruments or the kynar coating may be damaged.".
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Manufacturer Narrative
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Upon device inspection by aesculap technical services (ats), the following was observed: visual examination showed that the insulation on the shaft of the device had been damaged.The failure mode was confirmed.Root cause there was no evidence of a mis-repair.It can be assumed that it was caused by transportation or improper handling.The endoscopic instruments are not electrical instruments, and electrical testing may damage the kynar coating.According to the instructions for use (ifu): inadvertent contact with an activated electrosurgical device may result in injury to the patient or surgeon.This warning is in place because the device is not an electrosurgical device.Prestige graspers should be inspected for insulation damage before and after each use.If the coating becomes visually damaged due to normal wear and tear, it should be returned to aesculap for repair.Aesculap ifu is provided with the product and can be found on our website: www.Aesculapusa.Com/ifu.
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Search Alerts/Recalls
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