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

Catalog Number HAR36

Device Problem Device Inoperable (1663)

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

Event Date 03/16/2018

Event Type  malfunction  

Event Description

Two hand pieces did not work properly, they had to get a third before it worked.Manufacturer response for harmonic handpiece, (per site reporter): representative picked up the device and will initiate a quality control investigation.

• Brand Name: HARMONIC ACE
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 7618864
• MDR Text Key: 111733495
• Report Number: 7618864
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 12/08/2020
• Device Catalogue Number: HAR36
• Device Lot Number: 7689531/8098130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR