MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200873

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  malfunction  

Event Description

It was reported that the dell controller's shaver was not operating.Incident occurred before the procedure; therefore, there was no patient involvement.Preliminary results of investigation have concluded that a hand piece stall error message which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and observed no issues.A functional evaluation revealed a hand piece stall error message.The complaint was confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include connecting a hand piece that is still wet from sterilization processing or connecting a shorted out hand piece causing damage to the main board.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.The dyonics power ii control system operations/service manual states: to prevent damage to the control unit connector ports, do not plug in wet.Ensure that cleaned or sterilized cable connectors are completely dry prior to connecting to the control unit.

• Brand Name: DII CONTROLLER
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10216166
• MDR Text Key: 197094523
• Report Number: 1643264-2020-00445
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010607409
• UDI-Public: 3596010607409
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1