MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL HYSTEROSCOPY SET; UTERINE HYSTEROSCOPY

Model Number 50-250XL

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

Patient Problem Infiltration into Tissue (1931)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Lot of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is 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.

Event Description

It was reported that during the procedure, the physician dilated the patient and inserted the scope.A false passage was found.It is unknown if the scope or the dilator caused the false passage.The procedure was aborted.It is unknown if the uterus was perforated.No treatment given to patient.

• Brand Name: MYOSURE XL HYSTEROSCOPY SET
• Type of Device: UTERINE HYSTEROSCOPY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 8826734
• MDR Text Key: 152208752
• Report Number: 1222780-2019-00170
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-250XL
• Device Catalogue Number: 50-250XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other