MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR INCISOR DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72202536

Device Problems Sticking (1597); Noise, Audible (3273)

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

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a polypectomy procedure, while resecting, device seemed to stick and made a funny noise.The surgeon continued and completed the case with the same device.It was mentioned that there seemed to be a small reflective particle; the doctor continued to resect until there was no remaining particle.No patient injury or complications were reported.

Manufacturer Narrative

Inspection of the returned device did not identify any issues with the device.Visual inspection indicated that there was no damage to the device.The inner assembly rotated freely and the seal ring was seated properly.This blade functioned as designed.No manufacturing related effects were observed.After the evaluation the root cause for the reported issue could not be determined.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: TRUCLEAR INCISOR DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5850202
• MDR Text Key: 52193846
• Report Number: 3003604053-2016-00039
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202536
• Device Lot Number: F22998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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