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

Model Number 10-401FC

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem Perforation (2001)

Event Date 07/24/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text: 81.

Event Description

It was reported the blade got stuck in an open position and caused a uterine perforation.There was no other patient injury or medical intervention and the extended procedure time reported was 5-10 minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, it was received with the cutting blade in the open position.The cutting blade functionality was tested by manually twisting the drive cable coil on the drive cable plug to open and close the blade, however the blade would not open/close.The device was connected to the myosure controller unit to verify that the device blade would actuate when activated.When activated, the blade would not actuate in the cutting window, locking up and ultimately getting stuck in the console.During disassembly it was revealed that the internal wiring was wrapped around the device cable assembly.After soaking the blade in enzymatic cleaner for one hour and upon further disassembly of the returned complaint device the blade was found to be broken.The results of the visual inspection and functional testing determined that the reported event was confirmed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: user applies excessive force through hysteroscope, device enters patient in uncontrolled manner that causes damage to soft tissue inadequate device insertion reaction force experienced causing uncontrolled entry through hysteroscope, pushing device against healthy tissue excessive device withdrawal reaction force experienced, pulling device and hysteroscope against healthy tissue.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.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 as shown in figure 5.4.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.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.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.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the blade got stuck in an open position and caused a uterine perforation.There was no other patient injury or medical intervention and the extended procedure time reported was 5-10 minutes.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: 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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 17670338
• MDR Text Key: 322497883
• Report Number: 0001056128-2023-00021
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327507133
• UDI-Public: 07613327507133
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FCRR
• Device Lot Number: 14380387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention