MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC N/A; SCALPEL, ULTRASONIC, REPROCESSED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Event Description

The tip of the harmonic ace 7 shears with advanced hemostasis malfunctioned while being utilized in surgery.No patient harm.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC; 1810 west drake dr; tempe AZ 85283
• MDR Report Key: 7244443
• MDR Text Key: 99125590
• Report Number: 7244443
• 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: 01/11/2018,01/19/2018

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: Physician
• Device Expiration Date: 09/12/2018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR