MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP HANDPIECE HYSTER MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 7209807S

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: e-mail - (b)(6).(b)(4).

Event Description

It was reported that the trueclear morcellator handpiece became hot and the trueclear morcellation control unit smelled like it was burning.A backup handpiece and control unit were reportedly used to complete the procedure with no reported procedural delay and no patient or or staff impact as a result.

Manufacturer Narrative

Visual inspection found no external damage of the device.Functional evaluation confirmed that the handpiece became hot during use but no burning odor was detected.The cable was disconnected from the handpiece and it was observed that the connector pins were bent in a manner that would be consistent with rotation of the cable during engagement of the pins.It is possible that the bent connector pins may have resulted in an incorrect current path that results in heating of the unit.No deficiencies in materials or workmanship were identified.The root cause of this event appears to be associated with incorrect alignment of the cable assembly when connecting to the handpiece.

• Brand Name: SVCE REP HANDPIECE HYSTER MORCELLATOR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5451769
• MDR Text Key: 39135181
• Report Number: 1643264-2016-00027
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

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: 7209807S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1