ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number EPS07 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch #unk.Attempts are being made to obtain the device.To date no device has been received.If further details are received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
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Event Description
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It was reported that, during a total laparoscopic hysterectomy, the shaft was broken off during use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4).Date sent: 02/20/2020.D4: batch # t9452n.Device analysis: the device was received with no apparent damage, the electrode tip was intact and not broken off as reported by the customer.The instrument was tested for continuity and was found to be conforming.There were no anomalies noted with the functionality of the device.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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