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

Model Number	HARH45
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The facility stated the device was discarded.As the device was not returned for evaluation, inspection was unable to be performed.As the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor), user misinterprets generator signal , generator delivers less energy than displayed settings, tissue accumulation between the blade and shaft, activation against solid surfaces, repeated use of instrument beyond intended use, improper connection of instrument to hand piece, user activates on min instead of max.The instructions for use (ifu) state: 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.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.The instrument can be used for dissection, grasping, coagulation, and cutting between the blade and clamp arm.Note: to achieve complete sealing, the trigger should be fully closed and the vessel fully contained between clamp arm and blade of device.An audible and tactile "click" indicates full trigger closure.To achieve full closure of the jaws of the device, squeeze the plastic trigger until you feel it stop against the plastic handle (plastic to plastic).If full trigger closure is released prior to or during activation on tissue, an audible and tactile "click" is evident.Increase grip force until full trigger closure is achieved.For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the advanced hemostasis hand control button.Do not attempt to seal vessels in excess of 7 mm in diameter.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the patient vessel seal started to leak inside the bariatric patient post operation.The patient was brought back into surgery for repair and was discharged without future issue.There was no extended procedure time reported.These are commonly used devices that are readily available.
Event or Problem Description
It was reported that the patient vessel seal started to leak inside the bariatric patient post operation.The patient was brought back into surgery for repair and was discharged without future issue.There was no extended procedure time reported.These are commonly used devices that are readily available.
Additional 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.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 9087184
• Report Number: 0001056128-2019-00047
• Device Sequence Number: 2459824
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: 07613327346244
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161693
• 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,Followup
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: HARH45
• Device Catalogue Number: HARH45RR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention