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

Lot Number 1425698

Device Problems Defective Device (2588); Material Twisted/Bent (2981); Output Problem (3005)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Reprocessed myosure reach from stryker malfunctioned during procedure while running.Dr states a "clunking sound" occurred.The entire hose to the machine hub was jumping and twisting.It also caused the machine to shut down.The machine was restarted and a new hand piece attached and used accordingly.No harm to pt.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS
• MDR Report Key: 16305092
• MDR Text Key: 308937623
• Report Number: MW5114690
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1425698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White