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

Model Number	10-401FC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the case, the blade came off and were unsure if the piece was in the patient or in the shaft of the device.It was further reported an xray was performed and there was no broken piece found.There was no reported patient injury and extended procedure time reported was they needed to open an xl device and change the scope.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The returned complaint device was received with the stryker sustainability packaging and no packaging tray.There was evidence of bio-burden present on the device.The handle, shaft, blade, tubes, drive cable, and connector appeared intact upon initial inspection.Upon closer examination of the drive cable housing, a gap was observed at the connection point to the handle.The drive cable and internal wire separated easily and were found to be completely detached.The cutting blade was returned in the open position.No planarity damage to the outer shaft was observed.The device was disassembled to allow visual inspection of the inner shaft blade.The blade was intact and showed no signs of fracture.Microscopic examination revealed no evidence of damage or fragmentation.Device inspection confirmed a portion of the reported event related to material integrity; however, the allegation that the ¿blade came off¿ was not confirmed.It is likely that the drive cable separated or was damaged during use, resulting in the blade remaining in the open position and not being visible through the cutting window.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: improper handling during transit or at the facility site cable kinked or bent.Mechanical/electrical failure of the device gear assembly or myosure control unit or drive cable connection.Mishandling of device, excessive leverage applied to device.The instructions for use (ifu) state: before using the myosure tissue removal system for the first time, please review all available product information.Use only the myosure control unit to connect to the reprocessed myosure tissue removal device.Use of any other drive mechanism may result in failure of the device to operate or lead to patient or physician injury.Do not attempt to sharply bend the flexible drive cable in a diameter of less than 8 inches (20 centimeters).A sharply bent or kinked drive cable may cause the control unit to overheat and stop.During a procedure, a minimum distance of 5feet (1.5 meters) should be maintained between the control unit and the tissue removal device to allow the drive cable to hang in a large arc with no bends, loops, or kinks.If visualization is lost at any point during a procedure, stop cutting immediately.Periodic irrigation of the tissue removal device tip is recommended to provide adequate cooling and to prevent accumulation of excised materials in the surgical site.Ensure that vacuum pressure >200 mm hg is available before commencing surgery before using the myosure tissue removal system, you should be experienced in hysteroscopic surgery with powered instruments.Healthy uterine tissue can be injured by improper use of the tissue removal device.Use every available means to avoid such injury.Do not use the reprocessed myosure tissue removal device to resect tissue that is adjacent to an implant.When resecting tissue in patients that have implants, assure that: the reprocessed myosure tissue removal device¿s cutting window is facing away from (i.E.180 opposite) the implant.The visual field is clear; and the reprocessed myosure tissue removal device¿s cutting window is engaged in tissue and is moved away from the implant as tissue resection proceeds.In the event an implant becomes entangled with a myosure cutter, the following steps are recommended: cease cutting immediately: kink the reprocessed myosure tissue removal device¿s outflow tube to prevent a loss of uterine distension; disconnect the reprocessed myosure tissue removal device¿s drive cable from the control box; grasp the end of the reprocessed myosure tissue removal device drive cable with a hemostat or other clamping device; hold the drive cable hub and tissue removal device to prevent twisting; open the tissue removal device¿s cutting window by manually twisting the hemostat counterclockwise; and gently pull the reprocessed myosure tissue removal device into the hysteroscope to detach the myosure device from the implant.Operation.1.Push the power switch to the on position.2.The foot pedal activates tissue removal device operation.The foot pedal turns the motor on and off.Once the foot pedal is depressed, the reprocessed tissue removal device accelerates and rotates to the set speed and continues until the foot pedal is released.3.Press the foot pedal and observe the reprocessed tissue removal device action to verify that the motor runs and that the cutting window is closed.4.Introduce the reprocessed tissue removal device through the straight 3 mm working channel of a hysteroscope.5.Under direct hysteroscopic visualization, position the reprocessed tissue removal device¿s side facing cutting window against target pathology.Caution: excessive leverage on the reprocessed tissue removal device does not improve cutting performance and, in extreme cases, may result in wear, degradation, and seizing of the cutter assembly.6.Press the foot pedal to activate the reprocessed tissue removal device¿s cutting blade.7.The reprocessed tissue removal device¿s reciprocating action alternately opens and closes the device¿s cutting window to the vacuum flow thereby drawing tissue into the cutting window.8.Cutting takes place when the reprocessed tissue removal device cutting edge rotates and translates across the reprocessed tissue removal device¿s cutting window.Connecting reprocessed tissue removal device to the control unit 1.Remove the reprocessed tissue removal device (ref 10-401fc) from the sterile package.2.Sterile person hands the flexible drive cable and vacuum tubing to the non-sterile person.3.Non-sterile person inserts the flexible cable into the corresponding connection on the control unit.4.The reprocessed tissue removal device flexible drive cable has a keyed feature that serves to align the handpiece cable to the control unit connector.The metal tab on the connector is pushed down, the flexible cable inserted and then the tab is released.The reported event will continue to be monitored through post-market surveillance.

• 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: 25106901
• Report Number: 0001056128-2026-00032
• Device Sequence Number: 21520042
• Product Code: HIH
• UDI-Device Identifier: 07613327507133
• UDI-Public: 07613327507133
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 16282529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown