HOLOGIC, 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
Bowel Burn (1756); Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Di: (b)(4), h6: appropriate term not available.Code suggested: necrotic uterus.D4: 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.H3: 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.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) 2023, later the patient presented with necrotic uterus that required a hysterectomy and the removal of approximate 18 inches segment of the bowel due to a thermal injury.No other information is available.
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Search Alerts/Recalls
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