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

Model Number 10-401FE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

During surgery, the surgeon reported the reprocessed myosure device was not working properly.

Event Description

During surgery, the surgeon reported the reprocessed myosure device was not working properly.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 14851184
• MDR Text Key: 294912506
• Report Number: 14851184
• 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,Followup
• Report Date: 06/21/2022

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 Operator: Health Professional
• Device Model Number: 10-401FE
• Device Lot Number: 13495913
• 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: 06/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic