MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; SINGLE-USE REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS

Model Number	HAR9F
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the blade had been fragmented from the jaw and the fragmented tip was not returned for investigation.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: shipping damage, handling damage.Too much force or torque applied to instrument, or grasping/pulling scalpel blade tip or jaw broken or damaged, cleaning instrument or blade tip with abrasives.Applying pressure between instrument blade and tissue pad without having tissue between them.Keeping clamp arm open when backcutting or while blade is active without tissue between blade and tissue pad.Incidental and prolonged activation against solid surfaces, such as bone, metal or plastic.Attempting to bend, sharpen, or otherwise alter the shape of the blade.The instructions for use (ifu) state: a thorough understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments.Ensure that electrical insulation or grounding is not compromised.Do not immerse instruments in liquid unless the instruments are designed and labeled to be immersed.Audible high-pitched ringing, resonating from the blade or hand piece, are an abnormal condition and an indicator that the blade or hand piece is not operating properly.The ringing may be an indicator that the hand piece is beyond its useful life or that the blade has not been attached properly, which may result in abnormally high shaft temperatures and user or patient injury.Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.Avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips, or other instruments while the instrument is activated may result in cracked or broken blades, which may be identified by generator solid tone or instrument error.Scratches on the blade may lead to premature blade failure.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this happens, there may be a system failure signaled by a continuous tone or alert screen when either of the foot pedals or hand control buttons is depressed.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported during the procedure that the focus had broke.As reported, the handpiece was removed from the field and case proceeded.X-ray imaging was done after the procedure as the tip could not be located in the trash or which was negative for retained foreign body.Imaging confirmed that the metal tip was not inside of the patient.There was no other patient injury or medical intervention reported and there was no extended procedure time reported.These are commonly used devices that are readily available.
Event or Problem Description
It was reported during the procedure that the focus had broke.As reported, the handpiece was removed from the field and case proceeded.X-ray imaging was done after the procedure as the tip could not be located in the trash or or, which was negative for retained foreign body.Imaging confirmed that the metal tip was not inside of the patient.There was no other patient injury or medical intervention reported and there was no extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information: serial number updated to (b)(6).

• Brand Name: NA
• Common Device Name: SINGLE-USE REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
• 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: 20729953
• Report Number: 0001056128-2024-00096
• Device Sequence Number: 8370470
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170456
• 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,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• Device Lot Number: 16160833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: Required Intervention
• Patient Sex: Unknown