MAUDE Adverse Event Report: STERILMED, INC. HARMONIC ACE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2018

Event Type  malfunction  

Event Description

During a total laparoscopic hysterectomy, the harmonic shears broke.During the case, the technician noticed that the shears did not look right.The surgeon took them out of the patient and found the tip on the bottom of the shears broken and missing.We immediately replaced it and took the broken harmonic shears to the dirty utility room.An x-ray was taken at the end of the case to verify it's location.The missing piece was not seen in the patient.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n. ste. 100; maple grove MN 55369
• MDR Report Key: 7288560
• MDR Text Key: 100678858
• Report Number: 7288560
• Device Sequence Number: 0
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: HARH36
• Device Lot Number: P93X2L
• 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: 02/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO