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

Model Number	HAR1136
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device functioned normally for the majority of the case until there was an issue in which the generator prompted staff to remove the device from the patient.Upon inspection, it was noted that a fragment of the blade was missing.The fragment was retrieved from the patient and placed into a container to be shipped to the manufacturer for investigation.The fracture occurred during a hysterectomy while the jaws were open, and the back cutting method was used to cut tissue against a metal rumi.It was noted that the actuating blade should avoid contact with plastic and metal while the jaws are being activated, as per the manufacturer's instructions for use (ifu).As reported, x-rays were used to ensure no material was left post op.There was no other patient injury or medical intervention reported and extended procedure time reported was 35 minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the blade was returned fractured.The fractured/distal tip portion of the blade was not returned for investigation.The device inspection indicated that the complaint was confirmed for the reported failure mode.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: - too much force or torque applied to instrument, or grasping/pulling.- 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.The instructions for use (ifu) state: - verify compatibility with generators.Use device only with ethicon endo-surgery generator g11 (gen11) software version 2018-1 or later.Software revision can be found under ¿system information¿ in the generator g11 (gen11) ¿settings¿ menu.Refer to the generator g11 (gen11) operator¿s manual for more information.- 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 scratches on the blade, cracked or broken blades and premature blade failure.- audible high-pitched ringing, resonating from the blade, is an abnormal condition and an indicator that the blade is not operating properly.This may result in abnormally high shaft temperatures and user or patient injury.- 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.- 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 occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message.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: 22332963
• Report Number: 0001056128-2025-00046
• Device Sequence Number: 15685935
• Product Code: NLQ
• UDI-Device Identifier: 07613327586589
• UDI-Public: 07613327586589
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: HAR1136
• Device Catalogue Number: HAR1136
• Device Lot Number: 16298413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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