MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number 0406900000

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

It was reported during a surgical procedure at the user facility the device had no impedance resulting in the procedure being cancelled.There was no medical intervention or adverse impact on the patient reported.

Manufacturer Narrative

The reported device was not received for evaluation; event was not confirmed.The customer did not return the device for evaluation as they reported it was working properly after an electrode was replaced.The account did not return for evaluation.

Event Description

It was reported during a surgical procedure at the user facility the device had no impedance resulting in the procedure being cancelled.There was no medical intervention or adverse impact on the patient reported.

• Brand Name: MULTIGEN RADIOFREQUENCY GENERATOR
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5586835
• MDR Text Key: 42993061
• Report Number: 0001811755-2016-00388
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2016
• 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