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

Model Number	ACE45E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated the facility has not released the device for investigation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the reported event could be attributed to: jaws/blade subassembly damage or separation.Too much force or torque applied to instrument, or grasping/pulling.Scalpel blade tip or jaw broken or damaged, cleaning instrument or blade tip with abrasives.Incidental and prolonged activation against solid surfaces, such as bone, metal or plastic.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.Should the device become available for return, the investigation will be reopened at that time.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the harmonic scalpel broke off inside the patient.Multiple attempts were made to obtain additional information.No information was provided.However, there was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
On 6/14/2017, additional information was received from the reporting facility regarding the reported event.The executive summary has been updated with this information.
Event or Problem Description
It was reported that the tip of the harmonic scalpel broke off inside the patient's abdomen.X-ray was taken to retrieve the broken piece.The broken piece was retrieved with another instrument and the device was replaced, leading to a delay of 5 - 10 minutes.The procedure was completed successfully.There was no patient injury 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: 6639377
• Report Number: 0001056128-2017-00082
• Device Sequence Number: 954167
• Product Code: NLQ
• UDI-Device Identifier: 00885825016326
• UDI-Public: (01)00885825016326(17)191111(10)5274788
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K043315
• 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): 06/20/2017

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: 11/11/2019
• Device Model Number: ACE45E
• Device Catalogue Number: ACE45ERR
• Device Lot Number: 5274788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1