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

Catalog Number 10-401FC

Device Problems Failure to Cut (2587); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Stryker reprocessed myosure reach jammed immediately and didn't cut.Then hooked up the second stryker reprocessed myosure reach which worked for a while, but began making an unusual sound then jammed irrevocably and was unable to cut.

• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 13288695
• MDR Text Key: 284020788
• Report Number: 13288695
• 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
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 10-401FC
• Device Lot Number: 13037384
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1