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

Model Number ACE45E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, "a piece of the ace45e harmonic jaw fell off." the portion of the jaw was retrieved laparoscopically with no complications.The procedure was completed successfully with no adverse consequences, medical intervention, or delay in procedure.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.Visual examination of the returned device revealed evidence of clinical use including biological material on the distal tip as well as an indentation in the teflon pad.Visual inspection confirmed the reported issue as the blade was broken off.A review of the lot control sheet for the reported device indicated the device passed all inspections prior to release from sss.The results of the investigation performed indicated that the blade of returned device broke as a result of the blade contacting a hard object, possibly a staple or surgical clip, during clinical use (i.E.End user technique contrary to the ifu)."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.¿ this report is being filed as a malfunction due to sss being in a 2 year reporting cycle due to an event in which the tip broke off of the device and x-ray was used to ensure no remnants of the device were left in the patient.

• Brand Name: NA
• 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 ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 4056739
• MDR Text Key: 4730323
• Report Number: 0001056128-2014-00102
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2014

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: 02/28/2017
• Device Model Number: ACE45E
• Device Catalogue Number: ACE45ERR
• Device Lot Number: 2913583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• 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