MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. MYOSURE XL; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 50-601XL

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

During surgery to remove a fibroid, myosure device #1 did not cut properly and had to be replaced.

• Brand Name: MYOSURE XL
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr; tempe AZ 85283
• MDR Report Key: 14873663
• MDR Text Key: 295040387
• Report Number: 14873663
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 47746471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: Black Or African American