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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Whilst using reprocessed harmonic handpiece har9f, the minimum button was sticking and going off when nobody was touching the handpiece.

• Brand Name: N/A
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 9995157
• Report Number: 9995157
• Device Sequence Number: 11282009
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248(17)221216(10)11355289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 04/22/2020
• Report Date (Section F): 04/22/2020

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: HAR9F
• Device Lot Number: 11355289
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 87
• Date Report Sent to FDA: 04/22/2020