MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-601XL

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/11/2023

Event Type  Injury  

Event Description

It was reported that during a myosure procedure on (b)(6) 2023, the procedure was completed successfully, and at the end of the procedure the physician accidentally stopped on the foot pedal activating the myosure device while it was in the techs hands for cleaning.It was reported that the tech suffered a finger injury.No more details regarding the case are available.

Manufacturer Narrative

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 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.

• Brand Name: MYOSURE XL
• 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: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 16899472
• MDR Text Key: 314886332
• Report Number: 1222780-2023-00161
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045507654
• UDI-Public: 15420045507654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181974
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other