MAUDE Adverse Event Report: HOLOGIC, INC ACESSA PROVU SYSTEM; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 7300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pelvic Inflammatory Disease (2000)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.

Event Description

It was reported that a patient received an acessa procedure on an unknown date and that it went uneventful.But later the patient returned to the physician with pelvic inflammatory disease.No other information is available.

Manufacturer Narrative

Correction regarding previous submission please disregard the following statements : a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The correct statement is : 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.

• Brand Name: ACESSA PROVU SYSTEM
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 17242987
• MDR Text Key: 318269148
• Report Number: 1222780-2023-00226
• Device Sequence Number: 1
• Product Code: HFG
• UDI-Device Identifier: 00854763006140
• UDI-Public: 00854763006140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7300
• Device Catalogue Number: 7300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other