MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 15CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number PR15XT

Device Problems Bent (1059); Mechanical Problem (1384); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information requested and received: just to confirm, was the probe tip broken off? or, was there heat shrink damage? the tip broke off after it was removed from the patient, and is available for return.The doctor felt a pop, which told him the probe bent, which he confirmed upon removal from the patient.He then touched the tip, and it fell off.

Event Description

It was reported that the doctor placed probe into patient about 3 cm.He hit some cartilage and felt a pop.He removed probe and saw the probe was bent.He touched the tip, and it completely peeled off.No patient consequence reported.

Manufacturer Narrative

(b)(4).Lot ml17092978, work order (b)(4) was reviewed.There were no problems during the manufacturing or testing of this lot.A review of device data log was reviewed.A pr15, nm17nhb51138, was connected to channel 1 and tested successfully.This probe was disconnected.This is probably when the user noticed the "pop" and probe bend when removed.Another pr15, nm17nhb51155, was connected to channel 1 and tested successfully.The user cauterized for 15 seconds then 11 seconds.The probe was put into tissu-loc.A pr15, nm17nhb51149, was connected to channel 2 and tested successfully.The probe was put into tissu-loc.The probe cauterized for 25 seconds and then put into tissu-loc.Both probes were set to ablate for 8:00 at 65w.During the ablation, the time was increased to 10:00 for both probes.The ablation completed successfully.Probe 2 cauterized for 40 seconds.Probe 1 cauterized for 50 seconds.This was the end of the case.

Manufacturer Narrative

Product complaint # (b)(4).Date sent: 2/7/2018.The analysis found that one pr15xt probe was received.The broken probe tip verified.The root cause of the damage was the probe hitting the cartilage while being placed.Lot ml17092978, work order (b)(4) was reviewed.There were no problems during the manufacturing or testing of this lot.

Manufacturer Narrative

(b)(4).

• Brand Name: NEUWAVE PR XT PROBE 15CM 15GA
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st.; madison WI
• MDR Report Key: 7151280
• MDR Text Key: 96346134
• Report Number: 3008769756-2017-00021
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• PMA/PMN Number: K160936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PR15XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1