MAUDE Adverse Event Report: STRYKER SUSTAINABILITY Harmonic ACE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Event Description

During a laparoscopic appendectomy, the reprocessed harmonic scalpel did not work/cut and had to be replaced.There was no harm to the patient.

• Brand Name: Harmonic ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8603183
• MDR Text Key: 144812272
• Report Number: 8603183
• Device Sequence Number: 0
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2019,04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: 8871391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Date Report to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA