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

Model Number	HAR9FRR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use was identified.The jaw, handle, buttons and contact rings appear to be intact.The tip of the distal end of the blade was broken off and was not returned with the device.Gouges were observed on the cutting area of the blade.Due to the condition of the received complaint device, functional inspection could not be performed.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: - jaws/blade subassembly damage - incidental and prolonged activation against solid surfaces, such as bone or plastic the instructions for use (ifu) state: - 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.- 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.- scratches on the blade may lead to premature blade failure.- the entire exposed blade tip and any exposed blade shaft is active and will cut/coagulate tissue when the harmonic focus®+ shears blade is activated.Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue when using the harmonic focus + instrument.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that in an endocrine case, a tip of a harmonic focus shear (har9f) broke off during the case.The piece was retrieved.There was no patient injury or medical intervention and extended procedure time reported was less than five minutes.These are commonly used devices that are readily available.

• 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: 21583037
• Report Number: 0001056128-2025-00020
• Device Sequence Number: 15819571
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: HAR9FRR
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 14585502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Patient Sex: Unknown