MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HARMONIC ACE CURVED SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number ACE45E

Device Problems Break (1069); Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported that, "part of the jaw of the harmonic scalpel fell into the patient." the part was retrieved from the patient and the procedure was completed successfully.There was no medical treatment or intervention required and no adverse consequences as a result of this event.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.A visual examination of the returned device revealed evidence of clinical use including biological material on the distal tip.The distal tip of the scalpel blade was broken off and possessed scratches.Based on the damage observed, the most likely cause for the report was determined to be an impact of the blade with a hard object such as a staple or surgical clip during clinical use.Stryker sustainability solutions' instructions for use state: "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." a review of the lot control sheet for the reported device serial number indicated the device passed all inspections prior to release from sss.This report is being filed as a malfunction due to sss being in a 2 year reporting cycle due to mdr report 1056128-2013-00195 where the tip of the device fell into the patient and the patient had to be opened up to remove the tip of the device even though there was no patient injury in this event.The reported event is not occurring more frequently or with greater severity than is usual for the device.

• Brand Name: HARMONIC ACE CURVED SHEARS
• 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: moira barton varty ; 5307 great oak drive; lakeland, FL 33815 ; 4807635300
• MDR Report Key: 3752122
• MDR Text Key: 4464810
• Report Number: 0001056128-2014-00046
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2014

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: 01/31/2017
• Device Model Number: ACE45E
• Device Catalogue Number: ACE45ERR
• Device Lot Number: 2830917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2014
• 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