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

Model Number	HAR36
Medical Device Problem Codes	Melted (1385); Environmental Particulates (2930)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed an indentation in the teflon pad and evidence of clinical use was identified.The blade, jaw, teflon pad and contact rings appear to be intact.Functional inspection showed the device exhibited smoke on every cut and no alarms appeared on the generator during the cuts.A review of the dhr supports that the device met all inspection and test criteria prior to release.Therefore, the most likely root cause(s) are improper cleaning of blade/jaw during clinical use and tissue/fluid accumulation between the blade and jaw.The instructions for use (ifu) for the received device (har36) indicates the following: - blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.- 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.- as with all energy sources (electrosurgery, laser, or ultrasound), there are concerns about the carcinogenic and infectious potential of the by-products, such as tissue smoke plume and aerosols.Appropriate measures such as protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.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 reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that during the case, smoke began to fill in the cavity as a harmonic scalpel (har36) was grabbing tissue.They had to de-insufflate the cavity to get rid of the smoke.When the device was removed, the teflon pad was reported to have melted off.There was no patient injury and extended procedure time reported was minimal 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; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6946505
• Report Number: 0001056128-2017-00125
• Device Sequence Number: 11040736
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)180622(10)6601493
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133672
• 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): 10/12/2017

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 Expiration Date: 06/22/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 6601493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1