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

Model Number 10-401FC

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Myosure machine was used.Reprocessed myosure reach lot #13904268 was used for the case.This reprocessed myosure reach got stuck in the machine.The wire that attaches to the green portion was stuck.That particular reprocessed myosure wasn't working properly.The staff called another staff member who brought in a different reprocessed myosure reach, but couldn't extract the first myosure out.The green wire was stuck in the myosure machine.The staff member tried putting in the previous myosure reach and pull out but that didn't work.The staff member grabbed a second myosure machine, and a brand new myosure reach, and those worked well.

• Brand Name: STRYKER
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 15939254
• MDR Text Key: 305051292
• Report Number: 15939254
• 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: 12/06/2022,10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 13904268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2022
• Date Report to Manufacturer: 12/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female