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| Model Number G31520 |
| Device Problems
Break (1069); Fracture (1260); No Apparent Adverse Event (3189)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/16/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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Investigation is still pending.A follow-up /final vigilance report will be submitted to include the investigation conclusions.
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Event Description
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During echo endoscopy with biopsy, when staff wanted to make a ponction, difficulty to get the needle out of the echoendo.Needle broke off into echoendoscope.When needle was retrieved staff noticed a lack of bevelled edge.Consequences: longer anesthesia.Use of new needle.Extra financial cost.
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Manufacturer Narrative
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The complaint device was returned and evaluated on 19-feb-2020 and was confirmed to be broken in 4 places, 3 proximal breakages and 1 distal breakage.The reported complaint device was an echo-19 but the device, but an echo-hd-19-a device was returned.Confirmation of the correct rpn of the complaint device has been requested.Investigation is still pending.A follow-up /final vigilance report will be submitted to include the investigation conclusions.
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Event Description
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During echo endoscopy with biopsy, when staff wanted to make a ponction, difficulty to get the needle out of the echoendo.Needle broke off into echendoscope.When needle was retrieved staff noticed a lack of bevelled edge.Consequences: longer anesthesia.Use of new needle.Extra financial cost.
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Event Description
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During echo endoscopy with biopsy, when staff wanted to make a punction, difficulty to get the needle out of the echoendo.Needle broke off into echendoscope.When needle was retrieved staff noticed a lack of bevelled edge.Consequences: longer anesthesia.Use of new needle.Extra financial cost.
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Manufacturer Narrative
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Device evaluation: 1 unit of unknown lot number of echo-hd-19-a was returned not in its original packaging.Clarification was requested as follows; "can you please clarify that the needle broke at the distal (patient) end?" reply was received as follows; "it's the tip of the needle that broke off as well as the handle.The doctor told me he's stuck with a new pentax endoscope, he's got a big erector problem".Clarification was also requested as follows; "can you also please check with the rep if the broken needle part was retrieved and if so, by what means e.G.Forceps?" "how exactly did the needle handle break? if the answer is that it got stuck in the erector could he please elaborate as i am not clear what exactly this means" reply was received as follows; "the needle broke in several places because the doctor forced it out and destroyed it.The needle tip was removed with forceps.The endoscope has an erector so that the needle can be bent to take the right direction to the puncture site.This erector is located at the end of the endoscope and was defective." clarification was also received as follows "can you please clarify what the rpn of the complaint device? the rpn in trackwise is detailed as echo-19 but the complaint device which was retuned today was echo-hd-19-a" as no reply was received after several attempts the rpn and lot number was updated from echo-19 (lot c1571035) to echo-hd-19-a (unknown lot) due to the following rationale; - it was clarified through photos taken before and after the device was shipped of the broken handle failure detailed in the complaint.The locking ring needle location in the photos also corresponded.The photos of the packaging received back with the complaint device also correlate with the pc number ((b)(4)) in trackwise for this complaint.Finally the rpn of the device received could be confirmed from the detail on the needle handle as echo-hd-19-a lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 19 feb 2020.The returned device lab findings and observations can be referred through the attached files.The needle was observed to be broken in four places (1 distal and 3 proximal) the needle handle was also observed to be broken.Although not stated in the lab evaluation notes a proximal kink was also observed.After the lab evaluation clarification was requested as follows; "the returned device showed the needle was broken in 4 different places along with the broken needle handle can it be clarified how exactly these failures occurred and if they were all as a result of the erector problem which the rep mentions on his mail from 11th feb?" reply was received as follows; "the needle broke in several places because the doctor forced it out and destroyed it.The needle tip was removed with forceps.The endoscope has an erector so that the needle can be bent to take the right direction to the puncture site.This erector is located at the end of the endoscope and was defective." clarification was then requested from the product manager as follows; "do you know what part of the scope is the erector" reply was received as follows; "i am pretty sure it¿s a typo and the mean elevator" clarification was also requested as follows; "can you ask if the defective elevator (erector) caused the needle to break in the first place and then all following failures were as a result of the excessive force applied to remove the needle?" reply was received as follows; "that is indeed what happened.The faulty erector, elevator was defective, he had no choice but to force it out." as a result of the above confirmation this file is being written up a not a reject as the cook device was not the cause of the complaint.Document review including ifu review: prior to distribution, all echo-hd-19-a devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown the device history records could not be reviewed as part of the investigation.The notes section of the instructions for use, ifu0050-2, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0050-2).Root cause review: a definitive root cause can be attributed to a defective elevator of the scope which caused the needle to break in the first place and then all following failures were as a result of the excessive force applied to remove the needle.The advancement difficulty , kink and breakages are all as a result of the elevator issue and the force applied to the device during the procedure.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient required longer anesthesia.The needle tip was removed with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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During echo endoscopy with biopsy, when staff wanted to make a ponction, difficulty to get the needle out of the echoendo.Needle broke off into echendoscope.When needle was retrieved staff noticed a lack of bevelled edge.Consequences: longer anesthesia.Use of new needle.Extra financial cost.
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Manufacturer Narrative
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The reported complaint device was an echo-19 but the device, but an echo-hd-19-a device was returned.It has been confirmed that the correct rpn for this complaint is echo-hd-19-a.Investigation is still pending.A follow-up /final vigilance report will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Please note, this is a correction report.We were not aware that the device initially evaluated on the 19th of february for this complaint was actually related to a different (b)(4).This error was realised on 07-may-2020 and the investigation in this report will reflect the findings of the lab evaluation for the correct complaint device assessed on the 07th may 2020.Device evaluation 1 unit of lot number c1571035 of echo-19 was returned in its original packaging.It should be noted that this file is related to another complaint file.For details of the other investigation please refer to (b)(4).Device with rpn echo-hd-19-a was returned in february 2020, lab evaluation confirmed device to be broken in 4 places, 3 proximal breakages and 1 distal breakage.This device was believed to be related to (b)(4) as it was believed to be correct device at the time, however this is now known to be wrong as actual complaint device for (b)(4) was received and evaluated in the lab on 07 may 2020.To date and to best of our knowledge no complaint had been reported to customer complaints in relation to this complaint device returned in february 2020.Details of complaint issue in relation to device returned in february 2020 have been requested and received from sales rep and (b)(4) now opened in relation to that device it should be noted that this file was also related to another complaint file (b)(4).However, after review this file was cancelled as it is now possible to link the proximal kink with the defective scope elevator (erector) detailed as the root cause for (b)(4).Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 07 may 2020.The returned device lab findings and observations can be referred through the attached files.The distal tip of the needle was observed to be broken and the distal tip of the sheath was also observed to be damaged.A proximal kink was observed below the sheath extender.Clarification was requested as follows; question for both (b)(4).Manufacturer investigator is asking in relation to the deice which was retuned in february (which is now (b)(4)), the rep confirmed at that time that the root cause for the issue with that device was a faulty elevator (erector).Am i to assume that this explanation is not relevant for the device which was returned to cirl and evaluated in the lab last week ((b)(4))? the device evaluated in the lab last week had a distal needle break and distal sheath damage (as well as a proximal kink below the sheath extender).Reply was received as follows; - in fact, the doctor had the same problem on the same day.He damaged both needles in the same way.It was a problem with the endoscope¿s erector.It wasn¿t the needles that were the problem, it was the faulty endoscope.Clarification was requested from the product manager as follows; "do you know what part of the scope is the erector" reply was received as follows; "i am pretty sure it¿s a typo and the mean elevator".Document review including ifu review: prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl a review of the manufacturing records for echo-19 of lot number c1571035 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use, ifu0101-1 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).Root cause review: a definitive root cause can be attributed to a defective elevator of the scope which caused the distal needle break and distal sheath damage.The proximal kink below the sheath extender would likely have occurred as a result of the excessive force applied to remove the needle as per rep¿s comment, ¿he damaged both needles in the same way¿ the needle break, sheath damage and kink are all as a result of the elevator issue and the force applied to the device during the procedure.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient required longer anesthesia.The needle tip was removed with a forceps.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Please note, this is a correction report.We were not aware that the device initially evaluated on the 19th of february for this complaint was actually related to a different (b)(4).This error was realised on 07-may-2020 and the investigation in this report will reflect the findings of the lab evaluation for the correct complaint device assessed on the 07th may 2020.During echo endoscopy with biopsy, when staff wanted to make a ponction, difficulty to get the needle out of the echoendo.Needle broke off into echendoscope.When needle was retrieved staff noticed a lack of bevelled edge.Consequences: longer anesthesia.Use of new needle.Extra financial cost."as per complaint form": during echo endoscopy with biopsy, the doctor put the needle in the channel, he get difficulty.In place for biopsy, the needle don't get out the scope, when was retrieved the needle she was broken off into the scope.Consequence: they used a second needle."as per complaint form, received 26/05/2020) during echo endoscopy, the needle had trouble getting out of the operating channel, there was a problem with the endoscope.
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Manufacturer Narrative
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Imdrf annex g code: g07001 - part/component/sub-assembly term not applicable investigation amended the 18-feb-2021: 'complaint is not confirmed as the cook device was not the cause of the complaint'.
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Event Description
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A correction was made to the investigation conclusions on the 18-feb-2021, the investigation was amended to outline that the complaint is not confirmed.This supplement report is being submitted as a correction report.
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