MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC HARMONIC ACE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587)

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

Event Date 08/14/2019

Event Type  malfunction  

Event Description

While testing equipment, failed error noted, changed handpiece, test passed, when making first cut, unit failed.

Event Description

While testing equipment, failed error noted, changed handpiece, test passed, when making first cut, unit failed.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8949574
• MDR Text Key: 156114991
• Report Number: 8949574
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/21/2019,08/20/2019

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 Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: T93F03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Weight: 39