MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. HARMONIC FOCUS SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR9F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the physician was using reprocessed harmonic focus shears.The harmonic did not pass the test the first time, so they replaced the cord.It still did not work, so they got another handpiece and tested again.The second handpiece did not pass.A new harmonic machine was retrieved and both handpieces were retested.Neither handpiece worked with the new machine.Physician proceeded with the rest of the procedure without using harmonic.No harm came to the patient and the procedure was finished as planned.Manufacturer response for scalpel, ultrasonic, reprocessed, n/a (per site reporter).The rep has been notified and the device will be returned for failure analysis.Manufacturer response for scalpel, ultrasonic, reprocessed, n/a (per site reporter).The rep has been notified and the device will be returned for failure analysis.
Event or Problem Description
During the procedure the physician was using reprocessed harmonic focus shears.The harmonic did not pass the test the first time, so they replaced the cord.It still did not work so they got another handpiece and tested again.The second handpiece did not pass.A new harmonic machine was retrieved and both handpieces were retested.Neither handpiece worked with the new machine.Physician proceeded with the rest of the procedure without using harmonic.No harm came to the patient and the procedure was finished as planned.Update: it was discovered there was a software update on the generators that caused a stryker sustainability device to no longer be recognized.There was no equipment malfunction or manufacturing error for this event.Manufacturer response for scalpel, ultrasonic, reprocessed, n/a (per site reporter).The rep has been notified and the device will be returned for failure analysis.

• Brand Name: HARMONIC FOCUS SHEARS
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 7933484
• Report Number: 7933484
• Device Sequence Number: 11326509
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018
• Report Date (Section F): 09/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• Device Lot Number: 8446416
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 09/26/2018