Model Number 27030KBK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 02/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device will be forwarded to the manufacturing site in germany for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
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Event Description
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Customer reported that two cystoscopes were used in a cystoscopy case.Procedure went routinely without incident.There was no malfunction of the device during the case.Patient developed an infection, but reporter was not sure of the time lapse between the case and the infection onset.Patient returned to the hospital and is currently onsite being monitored.We subsequently learned it was a pseudomonas infection.The patient is still hospitalized but was reported to be doing much better.There were two cystoscopes used for the case, model 27030kak and 27030kbk.This report is for model 27030kbk (case (b)(4)).A separate mdr (case (b)(4)) will be submitted for model 27030kak.Additional patient information is not available.
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Manufacturer Narrative
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Received an update report from health department indicated there was no growth of p.Aeruginosa.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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The reported device was returned for evaluation.Visual and physical inspection were performed.The optic was examined in detail and damage was found at the distal end.The distal solder seam is mechanically damaged.There are also nicks and impacts in the distal edge area of the optic.Furthermore, dents are evident in the shaft.The optic was microbiologically sampled by the u.S.Department of health due to the infection that unfortunately led to the patient's death.No microbiological contamination was detected.Product history was also reviewed and found no deviation.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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