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

Model Number ACE36E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2014

Event Type  malfunction  

Event Description

It was reported, "the harmonic scalpel was working during the case when one side of the jaw broke off into the patient." the procedure was completed successfully with no delay.There was no patient injury, medical intervention, or adverse consequences as a result of this event.

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 also 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).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 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 a previous event in which the tip broke off and the patient had to be opened up to retrieve it.The reported event is not occurring more frequently or with greater severity than is usual for the device.

• 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: 4006072
• MDR Text Key: 4707181
• Report Number: 0001056128-2014-00090
• 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: 07/17/2014

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: 11/30/2015
• Device Model Number: ACE36E
• Device Catalogue Number: ACE36ERR
• Device Lot Number: 2750457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2013
• 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
• Patient Age: 25