Catalog Number SURGICAL UNKNOWN |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Abdominal Pain (1685); Unspecified Kidney or Urinary Problem (4503)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Qn#(b)(4).
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Event Description
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The report states that a "60-year-old man underwent a bilateral nerve-sparing robot-assisted radical prostatectomy.Sixty-three months after the operation, he complained of pain during urination or lower abdominal pain.From ct findings and flexible cystoscopy findings, it was diagnosed that the hem-o-lok clip used during robot-assisted radical prostatectomy had migrated in the bladder.The clip was encrusted with stones and attached to one end of the vesicourethral anastomosis.It was removed transurethrally with a holmium laser.First, the superficial calculus portion was removed with a holmium laser.Then, the adhering tissue was carefully excised and the clip was removed.No bladder perforation or postoperative recurrence was observed.Complaint was published in the japan medical abstract society (jamas), issued in 2022.Additional information is no longer available".
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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 could not be performed as the lot number and product code were no 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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Event Description
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The report states that a "60-year-old man underwent a bilateral nerve-sparing robot-assisted radical prostatectomy.Sixty-three months after the operation, he complained of pain during urination or lower abdominal pain.From ct findings and flexible cystoscopy findings, it was diagnosed that the hem-o-lok clip used during robot-assisted radical prostatectomy had migrated in the bladder.The clip was encrusted with stones and attached to one end of the vesicourethral anastomosis.It was removed transurethrally with a holmium laser.First, the superficial calculus portion was removed with a holmium laser.Then, the adhering tissue was carefully excised and the clip was removed.No bladder perforation or postoperative recurrence was observed.Complaint was published in the japan medical abstract society (jamas), issued in 2022.Additional information is no longer available".
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Search Alerts/Recalls
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