MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CABLE ASSEMBLY; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205788

Device Problem Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the dyonics power cable assembly would not stop providing power.There was no report of patient involvement or personal injury as a result of the reported event.

Manufacturer Narrative

The subject device was received on 12/2/2015 and confirmed to be serial number (b)(4).A visual inspection has discovered bent connector pins at the control unit cable connector.Functional testing is not possible as the discovered damage will not allow proper connection to the control unit.User error is suspected, it appears that a forceful twisting motion has been used to insert the cable connector into the control unit receptacle.As an aid, the cable connector and control unit receptacle have red dot markings that show the proper alignment for insertion.The complaint investigation has concluded that no defects in material or workmanship have been found.Device evaluated by manufacturer - yes.Updated evaluation codes to reflect the device evaluation.(b)(4).

• Brand Name: DYONICS POWER CABLE ASSEMBLY
• 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 ; 76 s. meridian ave.; oklahoma city, OK 73107-6512 ; 5123585706
• MDR Report Key: 5331452
• MDR Text Key: 35062271
• Report Number: 1643264-2015-00198
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• 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: Reuse
• Patient Sequence Number: 1