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Catalog Number 352168 |
Device Problem
Break (1069)
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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 08/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
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Event Description
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It was reported that: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
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Manufacturer Narrative
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Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73l1800731 was manufactured on 11/26/2018 a total of (b)(4) pieces.Lot was released on 12/06/2018.Dhr investigation did not show issues related to complaint.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and its jaws partially closed.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load as it got stuck in the bent rotation tab.After manually removing the clip and completing the trigger cycle, the next clip was protruding from the channel.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 10 clips remaining in the channel indicating that 5 clips were fired by the end user.A capa has been opened to further investigate this issue.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." the reported complaint of "can't be separated from applier" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 10 clips remaining in the channel indicating that 5 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.
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Event Description
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It was reported that: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
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Manufacturer Narrative
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Qn# (b)(4).This is a corrected follow-up report, including the "corrected additional manufacturer narrative." please make a note of it (see below): the device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 352168.A dimensional inspection was not required as part of this investigation.The device is not functional in current state.Damage is consistent with improper handling.Based on the visual review of the fracture plane and the customer's event description- it is very likely that this device was damaged in cleaning and was not adequately inspected prior to use on the patient.
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Search Alerts/Recalls
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