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

Model Number HARH36

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions (sss) for evaluation.The submitted medwatch form did not state if the device was available for return.Multiple attempts were made to the customer to arrange for device return.However, no other information regarding device return was provided from the facility.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: use error: too much force or torque applied to instrument, or grasping/pulling use error: applying pressure between instrument blade and tissue pad without having tissue between them use error: keeping clamp arm open when back cutting or while blade is active without tissue between blade and tissue pad use error: incidental and prolonged activation against solid surfaces, such as bone, metal or plastic.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.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.Do not introduce or withdraw the instrument with the jaws open through a trocar sleeve as this may damage the instrument.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm and distal shaft temperatures.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 Description

It was reported while using the harmonic scalpel, the white insulated pad at the tip started melting.Melting pieces were recovered and removed from sterile field.Multiple attempts were made to gather additional information regarding this specific event.However, no other information was provided from the facility.There was no patient injury, medical intervention, 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; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7541723
• MDR Text Key: 109502956
• Report Number: 0001056128-2018-00031
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: 07613327346251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2018
• Device Model Number: HARH36
• Device Catalogue Number: HARH36RR
• Device Lot Number: 7077227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 YR