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

Model Number	HARH45RR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the harmonic scalpel stopped working in the middle of case.Generator and handpiece being tested as well.There was no patient injury or medical intervention and the complainant is not aware of the duration of the extended procedure time.These are commonly used devices that are readily available.
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 blade was fractured and separated from the device tip.The broken tip was not returned with the device.The teflon pad, handle, and contact rings appears to be intact.Further inspection reveals the blade was not centered between the actuating shaft.Appears the width of the actuating shaft was bent inward.The device was then disassembled to inspect the scalpel rod.Inspection reveals gouges could been seen on the blade from contacting the inner geometries of the shaft assembly.The fracture was found high on the scalpel rod not in the cutting area of the blade.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: - applying improper or unnecessary directional or rotational force to connect instrument to hand piece - jaws/blade subassembly damage or separation - too much force or torque applied to instrument, or grasping/pulling.The instructions for use (ifu) state: - use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.- 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.- avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.- note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.- note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.The reported event will continue to be monitored through post-market surveillance.

• 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: 21561954
• Report Number: 0001056128-2025-00012
• Device Sequence Number: 19927281
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: 07613327346244
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202554
• 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): 03/10/2025

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: 11/17/2025
• Device Model Number: HARH45RR
• Device Catalogue Number: HARH45RR
• Device Lot Number: 14384354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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