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

Model Number N/A

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

Patient taken to the or on [redacted date] for operative hysteroscopy with resection of endometrial polyp, d&c for thickened endometrium seen on imaging.On [redacted date], it was discovered that the polyp which had been resected and collected using a myosure device had not been received in pathology.Per discussion with pathology, the collection bag was received and had tissue in it but there was no polyp tissue.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 19049520
• MDR Text Key: 339464126
• Report Number: 19049520
• 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: 03/15/2024,03/13/2024

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 Model Number: N/A
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 23L14RJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2024
• Date Report to Manufacturer: 04/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 33 KG
• Patient Race: White