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

Model Number	CA15L1
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fever (1858); No Code Available (3191)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 9171536
• Report Number: 3006451981-2019-00195
• Device Sequence Number: 2538065
• Product Code: NEY
• UDI-Device Identifier: 10884521189539
• UDI-Public: 10884521189539
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR