MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE REACH TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401

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

Patient Problem Sepsis (2067)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

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.3 devices were involved on this case: 1222780-2022-00418 / 1222780-2022-00420.

Event Description

It was reported on december 8th, that a patient went to the hospital after an accessa procedure, myosure resection, novasure endometrial ablation, and laparoscopic salpingectomy having sepsis.After the doctor performed a computerized tomography scan showed consistent endometritis, but the patient is doing better after iv antibiotics so no additional surgical interventions or pathology, the patient is being treated for a urinary tract infection.No additional information available.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16042363
• MDR Text Key: 306071739
• Report Number: 1222780-2022-00419
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• 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
• Report Date: 12/23/2022

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: 10-401
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACESSA PROVU HANDPIECE; NOVASURE V5 COMBO KIT, US, SINGLE PACK
• Patient Outcome(s): Other
• Patient Sex: Female