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Model Number 50-601XL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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Event Description
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It was reported that on (b)(6) 2021 , during a myosure xl procedure , the physician requested a foley catheter and discovered blood in the urine.An urologist was called and performed a cystoscopy and discovered damaged to the bladder, place a ureteral stent and placed suture in the bladder.Additional a laparotomy was performed and the damage was confirmed on the bladder , the uterus was examined and no damaged was observed.On (b)(6) 2021, it was reported that the patient was still hospitalized and that it had received a hysterectomy.No other information is available.
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Search Alerts/Recalls
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