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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Faculty surgeon while using reprocessed myosure lite tissue removal device, informed circulation nurse that device was not working.

• Brand Name: MYOSURE LITE TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 14842701
• MDR Text Key: 294863275
• Report Number: 14842701
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327507119
• UDI-Public: (01)07613327507119(17)250125(10)13527924
• 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: 06/14/2022

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: N/A
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 13527924
• 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: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White