MAUDE Adverse Event Report: HOLOGIC, INC OMNI HYSTEROSCOPE STANDARD SET; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 60-250-1

Device Problem Use of Device Problem (1670)

Patient Problem Uterine Perforation (2121)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported that during a myosure procedure on (b)(6) 2023, the physician perforated the uterus during the procedure.An omni scope and a myosure reach blade were being used.There was poor visualization due to a blood clot and it is unknown if the physician perforated when entering the cavity or when trying to clear the blood.The patient was given antibiotics and taken to recovery.No other information is available.

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.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: OMNI HYSTEROSCOPE STANDARD SET
• 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 ; CR 20102
• MDR Report Key: 16744352
• MDR Text Key: 313348958
• Report Number: 1222780-2023-00114
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045510357
• UDI-Public: 15420045510357
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-250-1
• Device Catalogue Number: 60-250-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other