MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

Catalog Number 72200873

Device Problems Circuit Failure (1089); Smoking (1585)

Patient Problems Dyspnea (1816); Dizziness (2194)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that there was a strong smoke development and short-circuit disturbance.An employee from the hospital was injury (breathlessness and daze) and got medical treatment.A backup device was available to complete the procedure with no significant delay.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with alarm sounding and "short circuit detected" error message on both ports a & b.Cause of alarm and error is shorted electronic components on the main pcb.Two transistors were shorted out and a resistor was burnt.Reason for electronic component failure is unknown but a shorted out mdu is a possibility.Product passed functional testing with a known good main pcb installed.The complaint investigation has concluded the cause of the failure to be defective electronic components on the main digital pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.No further impact to the two affected staff members is anticipated.

• Brand Name: DII CONTROLLER
• Type of Device: ARTHROSCOPE
• 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: jm gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8075333
• MDR Text Key: 127289144
• Report Number: 1643264-2018-00881
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607409
• UDI-Public: 03596010607409
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other