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 Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.

Event Description

It was reported that during the procedure, the scope was inserted but visualization was lost.The scope was removed and re-inserted.This when the perforation of the bowel and uterus is believed to occur.Patient was taken to the or for perforation repair."the patient is well and due to be discharged." no additional details available at this time.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: UTERINE HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, ma
• MDR Report Key: 10271352
• MDR Text Key: 198789368
• Report Number: 1222780-2020-00098
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 25420045510323
• UDI-Public: (01)25420045510323
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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
• Date Manufacturer Received: 06/15/2020
• 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