MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR9F
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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 detected.The blade, jaw, teflon pad appear to be intact.A gap near the min buttons was observed.The min and max buttons were pressed and released multiple times.It was observed the min button would remain in the down position when released.Compared to min button in off position, the min button would stick.There was no issues observed with the max button.The device was connected to a g11 scalpel generator (id# 0766, software rev 2014_1) using the appropriate hand piece (serial id# (b)(4)).The scalpel was tested and passed the initial testing.While pressing and releasing the min button it was observed that the device continued to activate.Min button was observed to stick during the functional testing.While the min button was stuck, the generator alerted both visually and audibly to indicate that the device was still activating.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore the most likely root cause of the reported event is handle halves separation due to improper connection of instrument to handpiece (improper torque wrench application technique used) or handling conditions subsequent to distribution from stryker.The instructions for use (ifu) state: do not torque the instrument by hand or damage may occur to the hand piece.Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece.Take care to avoid damage to the shears when removing the torque wrench from the instrument.Use the torque wrench to tighten the instrument onto the hand piece.Turn the wrench clockwise while holding the hand piece until it clicks twice, indicating that sufficient torque has been applied to secure the instrument.To ensure properly assembly, do not grip the instrument handle while applying torque with the torque wrench.Caution: do not torque the instrument by hand or damage may occur to the hand piece.Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece.Remove the torque wrench from the instrument.Do not discard the disposable torque wrench until the completion of the surgical case.The torque wrench is used for removal of the instrument from the hand piece following the procedure.In the event the torque wrench falls out of the sterile field, replace with a sterile torque wrench.Do not re-sterilize the disposable torque wrench.Caution: take care to avoid damage to the shears when removing the torque wrench from the instrument.While holding the hand piece, loosen the instrument by turning the torque wrench counterclockwise.Continue to loosen by turning the instrument manually to completely unscrew it from the hand piece.To avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable materials while not in use.During and following activation in tissue, the instrument blade and clamp arm may become hot.Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.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 that the harmonic scalpel kept firing and never turned off, continuous activation.The event occurred at the beginning of the case on the first try.The doctor removed the device and replaced it.There was no patient injury or medical intervention and minimal extended procedure time was reported to be a few minutes only to replace the device.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
A review of mdrs filed since february 20th, 2020, through august 5th, 2022, was conducted.Since february 20th, 2020, there have been no additional reports of serious injury or surgical intervention to preclude serious injury or permanent impairment related to this specific failure mode.Based on the analysis of mdr data compared to the firm¿s sales figures, the likelihood of this specific failure mode causing or contributing to another serious injury should the malfunction occur is considered remote.As such, we will no longer be reporting for the failure mode of ultrasonic scalpels (us) min activation button sticking resulting in continued activation.
Event or Problem Description
It was reported that the harmonic scalpel kept firing and never turned off, continuous activation.The event occurred at the beginning of the case on the first try.The doctor removed the device and replaced it.There was no patient injury or medical intervention and minimal extended procedure time was reported to be a few minutes only to replace the device.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 11772759
• Report Number: 0001056128-2021-00025
• Device Sequence Number: 11823450
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/11/2022

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: 12/08/2023
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 12393995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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