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

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Harmonic ace 7 stopped within a couple minutes of use during the procedure.Upon inspection, the tips were melted and pulling apart.

• Brand Name: N\A
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 14206146
• Report Number: 14206146
• Device Sequence Number: 14548830
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: (01)07613327346244(17)240817(10)13114413
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/11/2022
• Report Date (Section F): 04/11/2022

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: N/A
• Device Catalogue Number: HARH45
• Device Lot Number: 13114413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White
• Date Report Sent to FDA: 04/11/2022