HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESORIES)
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Model Number 7300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/11/2023 |
Event Type
Injury
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Event Description
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It was reported that an acessa procedure was performed 3 months ago, and the patient was presented to another hospital with severe abdominal pain.No uterine bleeding was found and the patient was diagnosed with dilated loops of bowel on imaging and elevated white count.The patient also had diagnostic laparoscopy and then converted to ex-lap for a total abdominal hysterectomy and bilateral salpingectomy.There was no bowel resection and the bowel was adherent to uterine serosa; once adhesions were released, serosal defects were seen with white soft degenerative tissue oozing out.This white material was also seen throughout the pelvis.No additional information available.
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Manufacturer Narrative
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Di: (b)(4).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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Search Alerts/Recalls
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