MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC HARMONIC ACE; INSTRUMENT, ULTRASONIC

Catalog Number HAR36

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem Test Result (2695)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

Tried to use the ace 36 harmonic and it kept resetting for no reason.Called clinical and they said disposable was not working right.Removed from service.
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manufacturer response for ace36 harmonic, (brand not provided) (per site reporter).
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rep was notified.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC; 5300 regions court; lakeland, FL 33815
• MDR Report Key: 4705516
• MDR Text Key: 18544851
• Report Number: 4705516
• Device Sequence Number: 1
• Product Code: NLQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HAR36
• Device Lot Number: 3405718
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 78