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

Model Number	HAR9F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection of the device revealed evidence of clinical use.Damage was observed on the surface of the teflon pad.Teflon pad was not lifted from the clamp arm t-rail.The tip of the distal end of the blade was broken off and returned with the device.Inspection of the blade coating revealed signs of erosion near a blade fracture as a result of activating against solid/hard materials.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 causes are: jaws/blade subassembly damage, incidental and prolonged activation against solid surfaces, such as bone or plastic.The instructions for use (ifu) state: 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 cracked or broken blades, which may be identified by generator solid tone or instrument error.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.Scratches on the blade may lead to premature blade failure.The entire exposed blade tip and any exposed blade shaft is active and will cut/coagulate tissue when the harmonic focus®+ shears blade is activated.Be careful to avoid inadvertent contact between all exposed blade surfaces and surrounding tissue when using the harmonic focus / instrument.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the tip of the harmonic scalpel (har9f) broke off two hours after the case started.The piece was recovered without issue.There was no patient injury, medical intervention, or extended procedure time reported.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; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7716130
• Report Number: 0001056128-2018-00046
• Device Sequence Number: 13770430
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170456
• 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
• Report Date (Section B): 07/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 7899664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1