MAUDE Adverse Event Report: H.S. HOSPITAL SERVICE SPA HS AMICA; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Lot Number LOT# 37210

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

14gx15cm amica probe tip malfunction following standard safety protocol resulting in dislodgement of the probe tip in the liver during ablation.The ablation was aborted within 15 seconds of the first ablation cycle.The probe was removed and a new 14gx15cm amica probe was used to re-attempt ablation.Following standard safety practice the new probe was inserted into the area of the tumor.After 1.5 min into the ablation cycle, the machine abruptly cut off due to similar issues as the first incident.The probe tip was also found to be dislodged in the liver.The lot numbers of these two devices were the same.Lot# 37210.Manufacturer response for apparatus for microwave ablation (amica) probe, amica probe (per site reporter).Https://www.Healthtronics.Com/sites/default/files/resources/amica%20information%20sheet.Pdf the radiology service made the local representative aware of the issue.This product is distributed by endocare, inc.- otherwise, amica doesn't have a united states office.

• Brand Name: HS AMICA
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): H.S. HOSPITAL SERVICE SPA
• MDR Report Key: 9659370
• MDR Text Key: 177383612
• Report Number: 9659370
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020,01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: LOT# 37210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA