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

Model Number ACE45E

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that the ultrasonic scalpel was defective; the jaw of the device was broken but not detached.There was no medical intervention or adverse consequences, and the procedure was completed successfully.The procedure was extended by five minutes due to the issue.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions (sss) for evaluation.Inspection of the returned device revealed biological material on the distal tip and an indention in the teflon pad.The device was actuated multiple times and confirmed to have unacceptable mechanical functionality.The jaw would stick in the close position and not open completely.The device was examined further and a build up of biological material was found on the distal tip.The device tip was cleaned, and jaw actuation was re-examined; the jaw was able to open/close without sticking.The device was then connected to a scalpel generator and appropriate hand piece.The scalpel was tested and gave an error code 5.The rod was inspected for fractures, and a crack in the blade was observed.A review of the device history record indicates the device met all inspection and test criteria prior to release.Therefore, the most likely root cause of the cracked blade is the blade contacting a hard object, possibly a staple or surgical clip, during clinical use.The instructions for use for harmonic ace curved shears 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.¿.

• 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: 4714087
• MDR Text Key: 5663659
• Report Number: 0001056128-2015-00029
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: ACE45E
• Device Catalogue Number: ACE45ERR
• Device Lot Number: 3437885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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