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

Catalog Number 7209807

Device Problems Device Slipped (1584); Unintended Movement (3026)

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

Event Date 08/01/2013

Event Type  malfunction  

Event Description

Won't lock window wouldn't lock and blade would skip.

Manufacturer Narrative

An investigation of the complaint of window lock malfunction was confirmed.The unit would not window lock.The root cause of malfunction can be contributed to a defective motor part number 8102263.This is the first reported occurrence for this failure mode.No corrective action(s) have been identified at this time.Complaint data will be monitored for this particular failure mode going forward.No further investigation is warranted at this time.(b)(4).

• Brand Name: TRUCLEAR HANDPIECE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: jim gonzales ; 120 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4827942
• MDR Text Key: 5843839
• Report Number: 1643264-2015-00022
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/08/2015

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?: No
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2013
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1