MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR INCISOR PLUS BLADE 2.9; HYSTEROSCOPE AND ACCESSORIES

Catalog Number 72202536

Device Problems Dull, Blunt (2407); Defective Device (2588)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

During an unknown procedure using a truclear incisor plus blade 2.9, it was reported that the blade appeared to be dull and defective; it would not window lock.The device did not break.Another incisor blade was used successfully to complete the procedure.There were no reports of patient injuries or complications.

Manufacturer Narrative

The device was marked as available for evaluation; although anticipated, the device has not yet been received.(b)(4).

Manufacturer Narrative

Inspection of the returned device did not identify any issue with the device.Visual inspection indicated that there was no damage to the device; the device was neither dull nor defective.The inner assembly rotated freely and the seal ring was seated properly.To test the connection to the handpiece, the device was fitted into truclear handpiece.The device seated and latched correctly in handpiece.The device window locked correctly.The fluid flow during window lock was inspected by connecting the device to a truclear handpiece and truclear control unit.The suction outflow was connected to a vacuum pump set to a pressure of 300 mmhg, the flow rate test result indicated the device met performance requirement.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.No further investigation is warranted at this time.(b)(4).

• Brand Name: TRUCLEAR INCISOR PLUS BLADE 2.9
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4853865
• MDR Text Key: 17579810
• Report Number: 3003604053-2015-00041
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

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 Expiration Date: 01/31/2018
• Device Catalogue Number: 72202536
• Device Lot Number: D64968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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