OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, VERTICAL, FIXED; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A22027A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyponatremia (4494); Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
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Event Type
Injury
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the available information.No device malfunction was reported in the study.Therefore, the suspect medical device is assumed to be meeting its specification.Based on the information available, the exact cause of the reported phenomena and the patients¿ outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
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Event Description
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Olympus received a study titled ¿monopolar transurethral resection of the prostate versus holmium laser enucleation in men with prostate volume greater than 100 ml¿.This retrospective study was aimed to compare the safety and efficacy of monopolar transurethral resection of the prostate (m-turp) and holmium laser enucleation of the prostate (holep) for prostate size >100 ml.Thirteen patients underwent m-turp (group 1), and 27 underwent holep (group 2).There were more complications in group 1 than group 2, especially for patients undergoing transfusion and with hyponatremia (2 in group 1 and 0 in group 2).At 3-month follow-up, the international prostate symptom score, quality of life score, and residual urine volume revealed no significant differences between groups.This study concluded that m-turp and holep in men with prostate volume greater 100ml had similar operative time, admission days and postoperative functional outcomes.However, higher transfusion rates and postoperative hyponatremia were noted in the m-turp group comparing to the holep group.The model number of the product (26-fr resectoscope) was unknown, but a representative product (a22027a) was chosen for processing purposes.No device malfunction was reported in the literature.Type of adverse events/number of patients: blood transfusion - 6 patients.Recatheterization - 4 patients.Urethral stricture - 1 patient.Urge urinary incontinence - 7 patients.
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Search Alerts/Recalls
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