MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. NEUWAVE; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number PR15

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot ml16112510, work order (b)(4) was reviewed.This lot was manufactured on 12/7/16 and the expiration date is 8/1/2020.One probe in this lot, sn (b)(4) failed to program.There were no other issues with the manufacturing or testing of this lot attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.What were the indications for ablation therapy? in the surgeon¿s opinion, what were the contributing factors that led to the probe breaking? what is the current patient status?.

Event Description

It was reported that during a bone ablation, after completing the second ablation in the pubic symphysis, with a pr15 probe, for three minutes at 65 watts, when the doctor went to remove the probe, the doctor thought the probe was still frozen and rocked the probe back and forth.The sales rep explained to the doctor that wiggling the probe in bone might crack the tip of the probe.The doctor pulled back on the probe and the probe came out without the tip.The patient was scanned, the tip of the probe was located inside the bone and the doctor filled the space with cement.

• Brand Name: NEUWAVE
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 6930268
• MDR Text Key: 89103970
• Report Number: 3005075853-2017-05323
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: PR15
• Device Lot Number: ML16112510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2017
• Date Device Manufactured: 12/07/2016
• 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