MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS MYOSURE REACH TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 10-401FC

Device Problem Intermittent Energy Output (4025)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

We were doing a hysteroscopy with the aqualex pump and needed to utilize the myosure device.The reprocessed myosure reach tissue removal device was plugged into the machine and when the foot pedal was pushed, it only turned on for about a second then turned off.This happened numerous times.

Event Description

We were doing a hysteroscopy with the aqualex pump and needed to utilize the myosure device.The reprocessed myosure reach tissue removal device was plugged into the machine and when the foot pedal was pushed, it only turned on for about a second then turned off.This happened numerous times.

• Brand Name: MYOSURE REACH TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 18078982
• MDR Text Key: 327450232
• Report Number: 18078982
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 10-401FC
• Device Lot Number: 14458165
• 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: 10/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White