MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW HYSTEROSCOPIC MORCELLATOR SYSTEM CONTROL UNIT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209808

Device Problem Smoking (1585)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

During a training by the sales representative, it was reported that the hysteroscopic morcellator system control unit started smoking prior to the procedure.Subject device will not be used.(b)(4).

Manufacturer Narrative

A visual inspection of the subject device confirmed damaged electronic components.Control unit short circuited and smoked.Per results of the investigation, the cause of the damaged components was unknown.It was concluded that the damage is most likely caused by an overloaded hand piece.The hand piece was not returned for evaluation.The unit was replaced under warranty.Root cause was determined as electrical component failure.At this time, no further investigation will be implemented.(b)(4).

• Brand Name: SMITH & NEPHEW HYSTEROSCOPIC MORCELLATOR SYSTEM CONTROL UNIT
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4855729
• MDR Text Key: 5845950
• Report Number: 1643264-2015-00029
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2015

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: Other
• Device Catalogue Number: 7209808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1