MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE +7 SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

Device not opening and closing properly.

• Brand Name: HARMONIC ACE +7 SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 17085918
• MDR Text Key: 316772369
• Report Number: 17085918
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2023

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 Model Number: N/A
• Device Catalogue Number: HARH36
• Device Lot Number: 14758546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2023
• Date Report to Manufacturer: 06/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1