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

Model Number 50-601XL

Device Problems Dull, Blunt (2407); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Patient had a large uterine myoma requiring the use of myosure size xl.All available xl's were reprocessed.The surgeon went through 5 as all were dull.The surgeon was unable to complete surgery before maxing patient fluid deficit of 2500 ml nacl.The surgeon stated about 70% of myoma removed requiring patient to return for another surgery to complete the removal of the myoma.Stryker company rep has been contacted; however, no pacakging was available to ascertain associated lot number(s) of reported defective device(s).We are requesting information ion how they check or verify sharpness of porducts.It is a reprocessed myosure blade from the company, one time use.

• Brand Name: MYOSURE XL TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 15592591
• MDR Text Key: 301630880
• Report Number: 15592591
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Date Report to Manufacturer: 10/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA