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

Model Number HAR9F

Device Problems Energy Output Problem (1431); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.Upon evaluation, the device passed functional testing.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore the most likely root cause(s) are: ancillary equipment issues (e.G.Generator, hand piece, and/or adaptor); user expectation of adaptive tissue technology functionality; improper usage and inadequate cleaning of instrument; user selects improper min settings on generator; applying improper or inadequate directional force; 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.Select the desired variable or minimum power level using the increase and decrease buttons on the generator.Minimum starting power level defaults to power level 3.For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type, pathology, and surgical technique.Max power is set at power level 5 and cannot be adjusted.The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the hand controls is depressed.Pressing either the left foot pedal of the foot switch or the proximal hand control (min) on the instrument activates the selected minimum power level.Pressing either the right foot pedal of the foot switch or distal hand control (max) on the instrument activates the maximum power level.The generator provides an audible tone to indicate when the instrument blade is active.The generator changes to a second activation tone as adaptive tissue technology regulates the delivery of energy.Thermal influences for optimal performance, clean the instrument blade and clamp arm throughout the procedure by activating the instrument tip in sterile saline.The instrument can be wiped with a sterile moist gauze sponge to remove tissue, if necessary.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the doctor stated that the device did not cut and cauterize well.A blood vessel did not seal, so they had to suture it closed.There was no patient injury or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

Event Description

It was reported the doctor stated that the device did not cut and cauterize well.A blood vessel did not seal, so they had to suture it closed.There was no patient injury or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 8480717
• MDR Text Key: 140876100
• Report Number: 0001056128-2019-00021
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (y/n): N
• PMA/PMN Number: K170456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 9623019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention