MAUDE Adverse Event Report: SMITH & NEPHEW, INC. O*CONTROL UNIT ASSEMBLY (EP-1); ACCESSORIES,ARTHROSCOPIC

Catalog Number 7205365

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/23/2013

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: international phone number (b)(6).An evaluation was performed on the returned product and the complaint of overheating could not be reproduced.Control unit passed functional testing using both hand pieces used at customer site when incident happened.Hand pieces were ran at high (10,000 rpms) during testing.Unit was tested for 48 hours with constant power applied.Unit was tested at 90 to 240 volts input to power supply.At no time during testing did unit overheat.A device history record review was conducted and found no inconsistencies (method code).No problem found.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that during a shoulder arthroscopy using a control unit after it was used for a couple of seconds and then being put on the arm of the patient, the patient experienced a burn in the region of the biceps muscle.A backup device was available to complete the case and there were no reported patient injuries or complications.

• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4940097
• MDR Text Key: 22884573
• Report Number: 1643264-2015-00068
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/23/2015

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 Catalogue Number: 7205365
• Device Lot Number: TM08625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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