ACESSA HEALTH INC. ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
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Model Number 7300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Abnormal Vaginal Discharge (2123)
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Event Date 12/10/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient received an acessa procedure on (b)(6), the patient was admitted to the hospital on (b)(6) due to pelvic pain, diarrhea and vaginal discharge, initially it was reported that the patient had possibly sepsis , bowel injury or an uterine abscess but after initial testing it was determined that no bowel injury could be detected via ct scan and that the patient was not septic but had some altered lab results that could be suggesting an infection, the cause of the infection is unknown.The physician mentioned the patient had pre existing health issues such as obesity and undiagnosed gastrointestinal disease.The patient was discharged from the hospital on (b)(6) with antibiotics and was recovering.No other information is available.
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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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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 a patient received an acessa procedure on (b)(6), the patient was admitted to the hospital on (b)(6) due to pelvic pain, diarrhea and vaginal discharge, initially it was reported that the patient had possibly sepsis , bowel injury or an uterine abscess but after initial testing it was determined that no bowel injury could be detected via ct scan and that the patient was not septic but had some altered lab results that could be suggesting an infection, the cause of the infection is unknown.The physician mentioned the patient had pre existing health issues such as obesity and undiagnosed gastrointestinal disease.The patient was discharged from the hospital on (b)(6) with antibiotics and was recovering.No other information is available.
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