Model Number IPN922791 |
Device Problems
Disconnection (1171); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that: "we used the lm gastro laryngeal mask to perform a duodenoscopy.At the end of the procedure, when removing the endoscope, the small distal cap which protects the optics was no longer attached to the endoscope.This required a fibroscopy check which revealed that the small cap was stuck at the level of the orifice of the laryngeal mask (mask endoscope channel too tight)." no patient injury, harm, or consequence reported.Patient condition reported as "no consequence for the female patient.".
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: "we used the lm gastro laryngeal mask to perform a duodenoscopy.At the end of the procedure, when removing the endoscope, the small distal cap which protects the optics was no longer attached to the endoscope.This required a fibroscopy check which revealed that the small cap was stuck at the level of the orifice of the laryngeal mask (mask endoscope channel too tight)." no patient injury, harm, or consequence reported.Patient condition reported as "no consequence for the female patient.".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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