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

Model Number 50-601XL

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.The facility did not save the device for return.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.The reported event could be attributed to: cable kinked or bent, mishandling and excessive leverage on the device.Introduce bend or kink during set-up or usage, and device not properly cleaned.The instructions for use (ifu) state: the reprocessed myosure xl tissue removal device for fluent.It is a hand-held unit which is connected to the fluent fluid management system via a 6-foot (1.8-meter) flexible drive cable and to the out-flopak via a 10-foot (3-meter) suction tube.Cutting action is activated by a foot pedal.The tissue removal device is a reprocessed single-use device designed to hysteroscopically remove intrauterine tissue.Before using the myosure xl tissue removal device for fluent, 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.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 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.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.Caution: the reprocessed tissue removal device is intended for single use only.Do not re-sterilize.Do not reuse.Do not lubricate tissue removal device.Discard tissue removal device after use.Dispose of the tissue removal device and packaging according to your facility¿s policies and procedures concerning biohazardous materials and sharps waste.Warning-danger: risk of explosion if used in the presence of flammable anesthetics.Connecting reprocessed tissue removal device to the control unit.Remove the reprocessed tissue removal device (ref 50-601xl) from the sterile package.Sterile person hands the flexible drive cable and vacuum tubing to the non-sterile person.Non-sterile person inserts the flexible cable into the corresponding adapter on the fluent fluid management system.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.Troubleshooting - if the device does not operate, check the following: (1) the fluent fluid management system is plugged into a wall outlet.(2) the wall outlet has power.(3) the power cord is attached to the rear of the fluent fluid management system.(4) the foot pedal is connected to the front of the fluent fluid management system.(5) the suction tubing is connected.If excess bending force is applied to the reprocessed myosure cl tissue removal device for fluent, the system may temporarily stop to prevent further damage.Do not use the reprocessed myosure xl tissue removal device for fluent to resect tissue that is adjacent to an implant.When resecting tissue in patients that have implants, assure that: the device¿s cutting window is facing away from (i.E.180° opposite) the implant; the visual field is clear; and the 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 device¿s outflow tube to prevent a loss of uterine distension; disconnect the device¿s drive cable from the fluent fluid management system; grasp the end of the 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 device into the hysteroscope to detach the reprocessed myosure xl tissue removal device for fluent from the implant.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 Description

It was reported that the surgeon had to open five different myosure devices for a procedure because they were not sharp enough.The surgeon was unable to complete surgery before maxing patient fluid deficit of 2500 ml nacl.The surgeon stated about 70% of the large uterine myoma was removed, requiring the patient to return for another surgery to complete the removal of myoma.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 15685990
• MDR Text Key: 302570101
• Report Number: 0001056128-2022-00039
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 07613327507140
• UDI-Public: 07613327507140
• 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
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XLRR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 32 YR