MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	50-601XL
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.The reported event could be attributed to: - mishandling of device, excessive leverage applied to device - cable kinked or bent - blunt blade or damaged blade - mechanical/electrical failure of the device gear assembly or myosure control unit or drive cable connection - device not properly cleaned.The instructions for use (ifu) state: - the myosure xl tissue removal device for fluent is only compatible with the fluent fluid management system.Use of any other motorized power source may fail to operate the device or lead to patient or physician injury.- the reprocessed tissue removal device flexible drive cable has a keyed feature that serves to align the handpiece cable to the fluent fluid management system connector.The metal tab on the connector is pushed down, the flexible cable inserted and then the tab is released.- the fluent fluid management system is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled.- the myosure xl tissue removal device for fluent is only compatible with the fluent fluid management system.Use of any other motorized power source may fail to operate the device or lead to patient or physician injury.- if the device does not operate, check the following: the fluent fluid management system is plugged into a wall outlet.The wall outlet has power.The power cord is attached to the rear of the fluent fluid management system.The foot pedal is connected to the front of the fluent fluid management system.The suction tubing is connected.- the reprocessed tissue removal device is eto sterilized.Verify that the reprocessed tissue removal device is sterile prior to use.Do not use if the package is opened or damaged.Discard all opened, unused devices.- do not use the device if the sterile package is open or appears compromised.Do not use the device if damage is observed.- before using the myosure xl tissue removal device for fluent for the first time, please review all available product information.- the reprocessed myosure tissue removal device should be stored at room temperature, away from moisture and direct heat.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the myosure blade was stuck in the open position form the beginning.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24514361
• Report Number: 0001056128-2026-00014
• Device Sequence Number: 18564907
• Product Code: HIH
• UDI-Device Identifier: 07613327507140
• UDI-Public: 07613327507140
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown