MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS EMPRINT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number CA15L1

Device Problems Failure to Fire (2610); Detachment of Device or Device Component (2907)

Patient Problems Fever (1858); No Code Available (3191)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during microwave ablation, after insertion of needle and when the generator started for ablation in ultrasound, there was no sign that the liver ablated due this the consultants wanted to extract needle.But as they extracted the needle, it broke from the mid to tip and its ceramic coating completely remained in the patient and they have to gave another incision to the skin to extract the broken needle.Extension of the incision by more than 1 inch.Change surgery from endoscopic to open surgery and there was unanticipated tissue loss or irreversible damage.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during microwave ablation, after insertion of needle and when the generator started for ablation in ultrasound, there was no sign that the liver ablated due this the consultants wanted to extract needle.But as they extracted the needle, it broke from the mid to tip and its ceramic coating completely remained in the patient and they have to gave another incision to the skin to extract the broken needle.Reoperation was initiated on the same day wherein surgery was changed from endoscopic to fluoroscopy and there was unanticipated tissue loss or irreversible damage.The ceramic tip was completely removed but extension of the incision by 3.5 centimeters.Patient continued to have high spikes of temperature and required 7 days of intravenous antibiotics after the extraction of needle through open skin incision.Fever was resolved after multiple episodes of injectable antibiotics.

• Brand Name: EMPRINT
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9171536
• MDR Text Key: 161685766
• Report Number: 3006451981-2019-00195
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 10884521189539
• UDI-Public: 10884521189539
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K133821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S7LG017X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR