HOLOGIC, INC ACESSA PROVU HANDPIECE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESORIES)
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Model Number 7300 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Bowel Perforation (2668)
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Event Date 09/28/2022 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6), 2022, an acessa procedure was performed, and prior start the procedure the physician perforated a portion of the bowel placing the trocar at the umbilicus.A general physician was called in and successfully repaired the injury with sutures and cleared all remaining adhesions from the abdomen prior to the acessa being performed by opening the patient.They sutured up the site, went back in laparoscopically and the physician successfully utilized acessa to ablate two posterior fibroids.No additional information is available.
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Manufacturer Narrative
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.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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