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

Model Number N/A

Device Problems Vibration (1674); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

Reprocessed myosure reach handpiece had excessive vibration and twisting when foot pedal engaged and did not advance smoothly through the myosure scope.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 12312190
• MDR Text Key: 266205879
• Report Number: 12312190
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 10-401FC
• Device Lot Number: 12557753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Date Report to Manufacturer: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA