MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problems Failure to Shut Off (2939); Temperature Problem (3022)

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

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device was running hot and would not turn off.There is no report of patient injury associated with this event.

Manufacturer Narrative

Evaluation - one service replacement powermax elite, part number 72200616s was received on 11/12/2015 and confirmed to be serial number (b)(4) as reported in the complaint.The reported complaint has been confirmed.Functional testing has found a short circuit in the hand piece control board.This short circuit condition is the most likely cause of the report of ¿running hot¿ the exact cause of the short circuit is unknown as the control board is sealed and cannot be properly disassembled.A random failure of an electronic component is assumed however all post market surveillance data will be monitored for similar trends going forward.No corrective actions are deemed necessary at this time.(b)(4).

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• Type of Device: SAW, POWERED, 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 ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5252948
• MDR Text Key: 32362189
• Report Number: 1643264-2015-00186
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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