MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ROD LENS HYSTEROSCOPE; UTERINE HYSTEROSCOPE

Model Number 40-250

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

Patient Problem Blood Loss (2597)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

Serial number of the 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.Serial 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 device as the identification numbers were not provided by the complainant.Internal reference#: (b)(4).

Event Description

It was reported that post procedure, upon dilation and curettage, the physician noted a large amount of bleeding and aborted the case.The physician believed a vessel was hit during the procedure.A catheter was inserted to stop the bleeding and the patient was transported to the hospital facility across the street for admission.It is estimated that about 300-500ml of blood was lost.Eventually the bleeding stopped.No perforation detected.No additional details available.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: UTERINE HYSTEROSCOPE
• 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: 8899479
• MDR Text Key: 155651266
• Report Number: 1222780-2019-00186
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091465
• 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: 07/26/2019

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: 40-250
• Device Catalogue Number: 40-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/15/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention