Model Number 2304.901 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer has been contacted.Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
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Event Description
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It was reported to richard wolf: "(b)(6) called (b)(6), the local rep, during the procedure.When the footswitch for the power drive art1 was activated, the controller displayed a "foot pedal defective" error message.The rep asked them to disconnect and re-connect the footswitch, and the message was no longer displayed.When they started the procedure, the handpiece wasn't rotating the burr.They disconnected the cable from the handpiece and generator, and re-connected.The handpiece still would not rotate the burr.Then the rep called me to conference with the operating room, and that's when the physician stopped the case.He had made an incision, stopped the case, closed the incision, and will re-schedule.(b)(6), the local sales rep went to the account and determined that the (2) 89955.0000 m4 motor handpieces and the 8564.851 connecting cable were functioning properly, and will not be returned to us for evaluation." will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.
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Event Description
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We received new information from the user facility about the patient and the procedure.See section a for patient information.Other information received: 1.Outcome attributed to adverse event: procedure stopped, incomplete.2.Purpose for procedure: treatment.3.What was the procedure: knee arthroscopy.4.Device serviced/repaired by a third party: no.5.Operator of device: surgeon and surgical tech.
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Manufacturer Narrative
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Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: the following fields have new information: section a (patient metrics), b5 additional information about procedure.
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Event Description
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Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device investigation and corrected informations.See h10.Rwmic mdr awareness date: 02-feb-2022.
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Manufacturer Narrative
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Follow-up report #2 is to provide fda with the results of the device investigation.The following fields have new information: b4, b5, d4 (udi#), d9, f7, f11, f13, and h10.Corrected data: a4, d4 (model#), d8, f3-5.According to rwgmbh investigation report device evaluation, form 5020 (12): device was returned but by-passed the complaint process.Complaint investigation is based on the assessment of the available information from the evaluation and repair performed under service order (b)(4).According the repair report, the sealing cap/rubber cap on the cover rocker switch is jammed, the device base was missing.The root cause is a material failure of the sealing cap/rubber cap produced and delivered between 2013 and 2014 from a supplier.This material failure occurs over time.The assosiated change request 9d-report from 12-07-2017 requires that during any maintenance or repair the defective material should be changed.However, there is no record about a maintenance or repair of the reported device since the delivery of (b)(6) 2015 either at rwmic's nor at rwgmbh's side.The user is advised in the related ifu ga-a 238-usa/usa/2012-10 v5.0/eco 2012-0554 & ga-a238-us/en/2020-12 v6.0/pk20-0352 about the regular maintenance of the device in section 7.2.1 maintenance intervals.Therefore, the delay and the cancellation of the procedure were caused by the failed maintenance of the device since delivery.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit an additional report if new information becomes available.
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Search Alerts/Recalls
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