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

Model Number	30-401LITE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation, inspection was unable to be performed.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 reported event could be attributed to: - ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor) - mishandling and excessive leverage on the device.Introduce bend or kink during set-up or usage - customer expectation 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 lite 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.- non-sterile person attached the tissue removal device vacuum tubing to the corresponding connection on the tissue trap of the collection canister - the proximal end of the vacuum tubing is connected to a collection canister.The vacuum pressure draws fluid and resected tissue through the tissue removal device¿s cutting window.¿ in the event an implant becomes entangled with a myosure cutter, the following steps are recommended: o cease cutting immediately: o kink the reprocessed myosure lite tissue removal device¿s outflow tube to prevent a loss of uterine distension; o disconnect the reprocessed myosure lite tissue removal device¿s drive cable from the control box; o grasp the end of the reprocessed myosure lite tissue removal device drive cable with a hemostat or other clamping device; o hold the drive cable hub and tissue removal device to prevent twisting; o open the tissue removal device¿s cutting window by manually twisting the hemostat counterclockwise; and o gently pull the reprocessed myosure lite tissue removal device into the hysteroscope to detach the myosure device from the implant.- caution: if it appears that the blade has stopped rotating during a procedure, check to ensure that all connections to the reprocessed tissue removal device and the control unit (both mechanical and electrical) are secure and that the drive cable has not wrapped into a loop.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.H3 other text : 81.
Event or Problem Description
It was reported that device failed during hysteroscopy, had to be removed from sterile field, and procedure was converted to dilation and curettage.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: N/A
• 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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 19027935
• Report Number: 0001056128-2024-00034
• Device Sequence Number: 17889031
• Product Code: HIH
• UDI-Device Identifier: 07613327507119
• UDI-Public: 07613327507119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/02/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2026
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITERR
• Device Lot Number: 14711570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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: Required Intervention
• Patient Sex: Unknown