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

Model Number	ACE14S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a review of the maude database, mdr report # 5670947 was discovered which alleged a malfunction occurred for a harmonic handpiece device from stryker instruments, lot # 4110409.It is known that stryker instruments does not manufacture these types of devices.A search of the lot # revealed the device was reprocessed by stryker sustainability solutions.The device was not returned to stryker sustainability solutions for evaluation and the reporter facility is unknown.As the device was not returned for evaluation, visual and functional 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.The reported event may be attributed to: - shipping damage, handling damage subsequent to distribution from stryker sustainability solutions - applying pressure between instrument blade and tissue pad without having tissue between them - prolonged activation (in general or against solid surfaces) - repeated use of instrument beyond intended use.The instructions for use (ifu) state: - take care to avoid application of pressure between the blade and tissue pad without tissue in between them as this can result in damage to the instrument.This may cause a system failure signaled by a continuous beep when either of the foot pedals is depressed.- avoid contact with any and all metal or plastic instruments or objects during instrument activation.Contact with staples, clips, or other instruments during instrument activation may result in premature blade failure, resulting in generator solid tone or instrument error.- clean blade, clamp arm, and distal end of shaft throughout procedure to achieve optimal performance and to avoid tissue sticking by activating the instrument tip in saline.Note: do not clean blade tip with abrasives.Instead, wipe with moist gauze sponge to remove tissue.If tissue is still visible, use hemostats to remove residue with generator in standby mode.Should information on the reporter facility become known, the investigation will be reopened.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the harmonic scalpel console alarmed and visually stated to remove from the patient.It was removed and then the machine stated to clean the tips.The tips were cleaned while the sheers were removed and a piece of the sheers broke off while cleaning.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: 6239369
• Report Number: 0001056128-2017-00006
• Device Sequence Number: 16360171
• Product Code: NLQ
• UDI-Device Identifier: 00885825014766
• UDI-Public: (01)00885825014766(17)181102(10)4110409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2017

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: 11/02/2018
• Device Model Number: ACE14S
• Device Catalogue Number: ACE14SRR
• Device Lot Number: 4110409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1