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

Model Number HAR9F

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Event 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 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
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 7933484
• MDR Text Key: 122672276
• Report Number: 7933484
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 09/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 77